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Product Notices

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 131

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 131

To: Customers and Distributors of Selectrol®

It is our intention to make the change listed below. The details of the change and the reason for it are given below.

If you have any difficulties or concerns accepting the change, please contact us immediately.

Product: MM30 Staphylococcus aureus NCTC® 7447 / ATCC® 6538P, 25 disc format

Product code: MM30-25 (25 disc)

Proposed Change Date: 1 June 2024

Change Details:

MM30, 25 disc format will become obsolete from the Selectrol® product range.

Reason for Change:

MM30 is currently available in 10 disc and 25 disc format. Following a review of product sales a commercial decision has been taken to make this Selectrol® strain available only in 10 disc format from 1 June 2024.

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Jun 2024

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 129

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 129

To: Customers and Distributors of Selectrol

It is our intention to make the changes listed below. The details of the changes and the reasons for them are given below.

If you have any difficulties or concerns accepting the change, please contact us immediately.

Product: Selectrol strains as detailed below.

Product code: Selectrol: MM03, MM29, MM97.

Proposed Change Date: 1 June 2024

Change Details:

The names of Selectrol strains MM03, MM29 and MM97 will change. Labels and certificates of analysis will be updated accordingly.

Product codeDesignationCurrent nameNew name from 01.06.24
MM03NCPF® 3100Candida kruseiPichia kudriavzevii
MM29NCTC® 10400 / ATCC® 10400Bacillus subtilisBacillus subtilis subsp spizizenii
MM97NCTC® 1621 / ATCC® 6939Rhodococcus equiRhodococcus hoagii

Reason for Change:

We have been advised that UKHSA has changed the names of the strains as above, so we are updating our documentation accordingly. There is no change to the NCTC strain number which remains the same.

Note:

ATCC® identification included for reference only

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Apr 2024

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 125a

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 125a

To: Customers purchasing stains

It is our intention to make the changes listed below. The details of the changes and the reasons for them are given below.

If you have any difficulties or concerns accepting the change, please contact us immediately.

Product: Giemsa and May Grunwald stains

Product code: Giemsa Stain - HS295 and May Grunwald Stain – HS445

Proposed Change Date: 1 April 2024

Justification:

TCS has recently carried out work to optimise the formulation of the Giemsa and May Grunwald stains to improve functionality.

The ingredients within the formulations remain the same but the proportions have been altered to optimise performance. An additional post-production filtration step has also been added.

The performance of these optimised stains has been assessed by an external laboratory with very positive feedback received.

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Feb 2024

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 124

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 124

To: Customers and Distributors of Selectrol and Accu-Bac

It is our intention to make the change listed below.

The details of the change and the reason for it are given below.

If you have any difficulties or concerns accepting the change, please contact us immediately.

Product: Selectrol and Accu-Bac strains Pseudomonas aeruginosa NCTC® 12924 / ATCC® 9027

Proposed Change Date: Selectrol: MM40, Accu-Bac: AB40

Proposed Change Date: 1 March 2024

Details: The names of Selectrol strain MM40 and Accu-Bac strain AB40 will change from Pseudomonas aeruginosa to Pseudomonas paraeruginosa. Labels and certificates of analysis will be updated accordingly. This name change will apply for MM40 and AB40 strains sold from 1 March onwards.

Reason for Change: We have been advised that UKHSA has changed the name of the strain as above, so we are updating our documentation accordingly. There is no change to the NCTC® strain number which remains the same.

Note - ATCC® identification included for reference only.

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Jan 2024

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 128

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 128

To: Customers purchasing Accu-Bac

It is our intention to make the changes listed below. The details of the changes and the reasons for them are given below.

If you have any difficulties or concerns accepting the change, please contact us immediately.

Product: Accu-Bac strains specified below.

Product code: All except those listed below .

Proposed Change Date: 19 January 2024

Change Details:

Certificates of Analysis for Accu-Bac strains will state geometric mean within the Viable Count section.

Reason for Change:

The first batches of Accu-Bac which were made available for sale stated arithmetic mean on the associated certificates of analysis. However, it has been decided that geometric mean will be more appropriate for future batches as this is industry norm.

Considerations:

Accu-Bac certificates of analysis will state the geometric mean except those batches listed below which state the arithmetic mean:

ProductStrain NameBatch
AB02Escherichia coli402175, 402175-L
AB04Klebsiella pneumoniae400602, 400602-L
AB17Enterococcus faecalis399455, 399455-L
AB26Klebsiella aerogenes401375, 401375-L
AB40Pseudomonas aeruginosa401712, 401712-L
AB75Escherichia coli401154, 401154-L

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Jan 2024

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 122

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 122

To: Customers purchasing Selectrol

It is our intention to change the source strain of the product listed below. The details of the change and the reason for it are given below.

The details of the change and the reason for it are given below.

If you have any difficulties or concerns accepting the change, please contact us immediately.

Product: Selectrol strain MM22 Proteus mirabilis

Proposed Change Date: 1 December 2023

Details: We will no longer be able to offer for sale MM22 Proteus mirabilis NCTC 11938. Instead customers will be able to purchase MM43 Proteus mirabilis NCTC 13376 / ATCC® 14153 or MM68 Proteus mirabilis NCTC 10975.

Reason for Change: We are continually reviewing the range of Selectrol strains that we offer for sale. Sometimes it is necessary to withdraw a strain from sale for various reasons, including low sales. This is the case with MM22 Proteus mirabilis.

Considerations: To enable customers to compare MM22 with alternative strains we will continue to make this available for sale until 01 February 2024. However, please be aware this batch with lot number 02200312 has a reduced shelf life of 2024.05.

We offer two other Proteus mirabilis strains in our Selectrol range - MM43 Proteus mirabilis NCTC 13376 / ATCC® 14153 and MM68 Proteus mirabilis NCTC 10975.

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Dec 2023

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 120

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 120

To: Customers purchasing Selectrol

It is our intention to change the source strain of the product listed below. The details of the change and the reason for it are given below.

If you have any difficulties or concerns accepting the change, please contact us immediately.

Product: Selectrol strain MM53 Candida krusei

Proposed Change Date: 06.11.2023

Change Details:

We will no longer be able to offer for sale MM53 Candida krusei NCPF 3953. Instead customers will be able to purchase MM03 Candida krusei NCPF 3100.

Reason for Change:

Vials of NCPF 3953 source strain (generation 0) used for manufacture of MM53 are no longer available in the National Collection of Pathogenic Fungi (NCPF) collection supplied by UKHSA.

An alternative source strain of NCPF 3100 has been purchased and will be available as MM03 Candida krusei in the TCS Biosciences catalogue .

Considerations:

MM03 is an alternative to MM53 and can be used as a replacement for this product

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Nov 2023

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 117

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 117

To: Customers and Distributors of Selectrol

It is our intention to make the change listed below. The details of the change and the reason for it are given below.

If you have any difficulties or concerns accepting the change, please contact us immediately.

Product: MM89 Salmonella poona, NCTC 4840, 25 disc format

Product codes: MM89-25 (25 disc)

Proposed Change Date: 1 July 2023

Change Details:

MM89, 25 disc format will become obsolete from the Selectrol product range.

Reason for Change:

MM89 is currently available in 10 disc and 25 disc format. Following a review of product sales a commercial decision has been taken to make this Selectrol strain available only in 10 disc format from 1 July 2023.

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Jun 2023

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 116

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 116

To: Customers purchasing Selectrol strains

It is our intention to change the Instructions for Use of the Selectrol range of products. The details of the change and the reason for it are given below.

If you have any difficulties or concerns accepting the change, please contact us immediately

Product: Selectrol

Product codes: All MM codes

Proposed Change Date: 1 July 2023 (or sooner if current IFU stocks run out)

Change Details:

Selectrol Instructions For Use (IFU) will change to a format that meets IVDR requirements. The IFU supplied in the clamshell pack with the Selectrol vial(s) will be in English only. Electronic versions of the IFU (eIFU) translated into all EU languages will be available on our website
https://www.tcsbiosciences.co.uk/qcerts/.

Reason for Change:

TCS continues to work towards meeting the requirements of the In Vitro Diagnostics Medical Device Regulation (IVDR) in accordance with the timeline for Class B devices. The IFU has been updated to include additional details (IVDR Annex II).

Considerations:

There is no change to the intended use of Selectrol. There is no change to the way in which Selectrol discs are to be removed from the vial or used on solid / liquid media by the end user. The IFU contains additional details including 'in use stability' and 'serious incident reporting'.

Conclusion:

The changes to the IFU have been made to meet the IVDR requirements. The IFU has been translated into all the languages of the EU and the translations are available electronically.

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Apr 2023

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 114

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 114

To: Customers and Distributors of StainHD product range

It is our intention to make a change as listed below. The details of the change and the reason for it are given below.

Please acknowledge receipt of this notification and confirm your acceptance of the change by completing the section in the foot of this document, and emailing a copy of the form to qc@tcsgroup.co.uk. Acceptance of the change is assumed if a response is not received within two weeks of issue of this notification.

If you have any difficulties or concerns accepting the change, please contact us immediately.

Product: HS380-1L Haematoxylin Weigert Solution B

Proposed Change Date: From 1 May 2023

Change Details:

We are discontinuing this product from our current catalogue of StainHD products.

Reason for Change:

We have been reviewing sales of our Horse and Sheep blood products. There are insufficient sales of the products listed in Appendix 1 to continue to include them in our catalogue from 2023.

Considerations:

This change control is issued to give customers and distributors as much advance notice as possible prior to implementation of the change. Until 1 May 2023 HS380-1L Haematoxylin Weigert Solution B will continue to be available for sale while stocks last.

For your information, a certificate of analysis will be available for each product on our website https://www.tcsbiosciences.co.uk/dyesandstains/

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Apr 2023

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 111

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 111

To: Customers purchasing Horse and Sheep Blood Products

It is our intention to make a change as listed below. The details of the change and the reason for it are given below.

If you have any difficulties or concerns accepting the change, please contact us immediately.

Product: Horse and Sheep Blood products as listed

Proposed Change Date: 01 January 2023

Change Details:

The products listed in Appendix 1 will no longer be available in our catalogue.

Reason for Change:

We have been reviewing sales of our Horse and Sheep blood products. There are insufficient sales of the products listed in Appendix 1 to continue to include them in our catalogue from 2023.

Considerations:

There are alternative products of equivalent volume available for some of the discontinued products as listed in Appendix 1.

Conclusion

Removal of the products listed in Appendix 1 from sale will have a minimal impact on customers as current sales of these products are very low. Alternative products are suggested in table 1.

Products no longer for sale from 01.01.23

Alternative products available in catalogue 2023

Product code

Product Description

Volume

Product code

Product Description

Volume

HB045

Horse Blood in ACD

25ml

HB047

Horse Blood in ACD

500ml

HB046

Horse Blood in ACD

100ml

HB047

Horse Blood in ACD

500ml

HB015

Horse Blood in ACD

2 Litres

HB047

Horse Blood in ACD

500ml

HB082

Horse Blood in EDTA

100ml

HB073

Horse Blood in EDTA

500ml

HB076

Horse Blood in EDTA

1 Litre

HB073

Horse Blood in EDTA

500ml

HB002B

Horse Blood Defibrinated (bag)

2 Litres

HB002

HB001B

Horse Blood Defibrinated (bottle)

Horse Blood Defibrinated (bag)

2 Litres

1 Litre

HB0035B

Horse Blood Defibrinated (bag)

500ml

HB035

HB001B

Horse Blood Defibrated (bottle)

Horse Blood Defibrinated (bag)

500ml

1 Litre

HB024

Horse Blood Lysed

400ml

HB038

Horse Blood Lysed

500ml

HB025

Horse Blood Lysed

200ml

HB038

Horse Blood Lysed

500ml

HB026

Horse Blood Lysed

300ml

HB038

Horse Blood Lysed

500ml

HB036

Horse Blood Lysed

25ml

HB037

Horse Blood Lysed

100ml

HB039

Horse Blood in Oxalate

25ml

HB040

Horse Blood in Oxalate

100ml

SB003

Sheep Blood Defibrinated (bottle)

2 Litres

SB003B

Sheep Blood Defibrinated (bag)

2 Litres

SB092

Sheep Blood Defibrinated (bottle)

250ml

SB055

Sheep Blood Defibrinated (bottle)

500ml

SB097

Sheep Blood Defibrinated

200ml

SB055

Sheep Blood Defibrinated (bottle)

500ml

SB065

Sheep Blood in ACD

25ml

SB007

Sheep Blood in ACD

1 Litre

SB066

Sheep Blood in ACD

100ml

SB007

Sheep Blood in ACD

1 Litre

SB067

Sheep Blood in ACD

500ml

SB007

Sheep Blood in ACD

1 Litre

SB079

Sheep Blood in ACD

600ml

SB007

Sheep Blood in ACD

1 Litre

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Dec 2022

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 109

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 109

To: Customers purchasing Bacticount Dipslides

It is our intention to change the Manufacturing Process of the products listed below. The details of the change and the reason for it are given below.

If you have any difficulties or concerns accepting the change, please contact us immediately.

Product: Bacticount Dipslides

Proposed Change Date: Dipslides manufactured June 2022 onwards

Change Details:

Bacticount Dipslides will no longer include a cap.

Reason for Change:

We have been informed by Dimanco, the manufacturer of dipslides, that the plastic caps will no longer be included with Bacticount Dipslides.

The rising costs of plastics raw materials and consideration of the environmental benefits, including reduction of carbon footprint, to not including caps with these products are the key reasons for this change.

Considerations:

There is no change to the standard 6 month shelf life of the products; however extended shelf life to 9 months will no longer be possible.

Conclusion

There is no effect on the quality of the products. The caps have been an aesthetic addition to the slides.

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Sep 2022

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 104

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 104

To: Customers purchasing Stain HD products

It is our intention to change the IVD status of the products listed below. The details of the change and the reason for it are given below.

If you have any difficulties or concerns accepting the change, please contact us immediately.

Product: StainHD products as specified below

Product codes: Product codes prefixed HS and HDS. HC6405 Periodic acid (1% aqueous)

Proposed Change Date: 26 May 2022

Change Details:

Products with codes as listed above will no longer be CE marked but will carry the UKCA mark.

From this date StainHD products will be available for UK sale, but no longer available for sale in the EU.

Reason for Change:

The products listed in this change control are currently CE marked in accordance with the IVD Directive.

These products will carry the UKCA mark in accordance with the UK Medical Devices Regulations 2002 (SI 2002 No. 618) as amended, for in-vitro diagnostic medical devices from 26 May.

The CE mark will be removed from these products from 26 May.

Considerations:

From 26 May 2022 Regulation 2017/746 the EU IVDR will come into force in the EU. This regulation will not apply to the UK. TCS Biosciences has taken the commercial decision not to transition the StainHD product range to IVDR, therefore the CE mark will be removed from these products and they will not be available for sale in the EU.

From 26 May 2022 IVD registration of the StainHD products with product codes listed above in Great Britain will be in accordance with the UK Medical Devices Regulations 2002 and thus the product labels will carry the UKCA mark.

Conclusion

The changes listed above have no effect on the formulation and quality of the StainHD products included in this change control.

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May 2022

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 98

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 98

To: Customers purchasing Stain HD products

It is our intention to change the Manufacturing Process of the products listed below. The details of the change and the reason for it are given below.

If you have any difficulties or concerns accepting the change, please contact us immediately.

Product: Stain HD Dyes and Stains

Product codes: HD codes, HS codes, HDS codes, HK codes

Proposed Change Date: 12 April 2022

Change Details:

An alternative bottle has been approved and may be used to supply 500ml and 1L volumes to customers.

Reason for Change:

Due to the current extraordinary circumstances of Covid-19 pandemic, world-wide shortage of plastics products and their constituent polymers, escalating oil prices and conflict in Ukraine we are currently unable to obtain HDPE bottles from our US supplier for use with 500ml and 1L volumes of products.

Instead, we will be supplying 500ml and 1L volumes of products in HDPE bottles from a UK supplier.

Considerations:

The UK supplier of bottles for both volumes is already an approved supplier with TCS Biosciences.

Although the bottles are different shapes, there is no difference between the two bottle types in terms of plastic used, both are manufactured using HDPE.

Our internal leak testing included filling bottles with aqueous and solvent-based stains, then storing the bottles inverted for at least 2 weeks. At the end of the test there was no evidence of leakage from any of the bottles.

Conclusion

We reserve the right to package our 500ml and 1L volume Stain HD products in HDPE bottles from either of two approved suppliers to ensure we can continue to provide these products to our customers.

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Apr 2022

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 94

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 94

To: Customers purchasing Selectrol

It is our intention to change the source strain of the product listed below. The details of the change and the reason for it are given below. Acceptance of the change is assumed if a response is not received within two weeks of issue of this notification.

If you have any difficulties or concerns accepting the change, please contact us immediately.

Product: Selectrol strain MM61 Candida tropicalis

Proposed Change Date: 30.04.2022

Change Details: We will no longer be able to offer for sale MM61 Candida tropicalis NCPF 3463. Instead customers will be able to purchase MM79 Candida tropicalis NCPF 3111 Reason for Change: Vials of NCPF 3463 source strain (generation 0) used for manufacture of MM61 are no longer available in the National Collection of Pathogenic Fungi (NCPF) collection supplied by UKHSA. An alternative source strain of NCPF 3111 has been purchased and will be available as MM79 Candida tropicalis in the TCS Biosciences catalogue.

Considerations: MM79 is an alternative to MM61 and can be used as a replacement for this product.

NOTE: MM61 will be available to order while stocks last.

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Apr 2022

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 87

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 87

To: Customers purchasing Selectrol and Accu-Bac It is our intention to change the names of the products listed below.

The details of the change and the reason for it are given below.

If you have any difficulties or concerns accepting the change, please contact us immediately.

Product: Selectrol strains MM26 and MM88; Accu-Bac strain AB26

Proposed Change Date: 01.03.2022

Change Details:

MM26 and AB26 Enterobacter aerogenes will become known as MM26 and AB26 Klebsiella aerogenes. MM88 Klebsiella aerogenes will become known as MM88 Raoultella planticola

Reason for Change:

These microorganisms are sourced from NCTC who have updated the names.

Considerations: All references to MM26, MM88 and AB26 will incorporate the name changes from 01 March. This includes all internal documentation, Selectrol labels and certificates, Accu-Bac labels and certificates.

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Mar 2022

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 94

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 94

To: Customers purchasing Selectrol It is our intention to change the source strain of the product listed below.

The details of the change and the reason for it are given below.

If you have any difficulties or concerns accepting the change, please contact us immediately.

Product: Selectrol strain MM54 Candida parapsilosis

Proposed Change Date: 08.03.2022

Change Details:

We will no longer be able to offer for sale MM54 Candida parapsilosis NCPF 8334. Instead customers will be able to purchase MM39 Candida parapsilosis NCPF 3104.

3104 Reason for Change:

Vials of NCPF 8334 source strain (generation 0) used for manufacture of MM54 are no longer available in the National Collection of Pathogenic Fungi (NCPF) collection supplied by UKHSA. An alternative source strain of NCPF 3104 has been purchased and will be available as MM39 Candida parapsilosis in the TCS Biosciences catalogue.

Considerations: MM39 is an alternative to MM54 and can be used as a replacement for this product.

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Mar 2022

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 95

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 95

To: Customers and Distributors of animal blood and serum products

It is our intention to change the status of the products listed below. The details of the change and the reason for it are given below.

If you have any difficulties or concerns accepting the change, please contact us immediately.

Product: Animal Blood and Serum products – see Appendix 1 for full list of products and product codes

Proposed Change Date: 26 May 2022

Change Details:

These products will no longer be classed as in vitro diagnostic products (IVDs). The labels for these products will not include the CE or IVD symbols.

Reason for Change:

Currently the products listed in Appendix 1 are classified as IVDs in accordance with Annex Ill of Directive 98/79/EC and a self-declaration of conformity is available for each product.

Directive 98/79/EC is to be replaced by Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) for which the date of application is 26 May 2022.

It is a requirement of the IVDR to reclassify all IVDs in accordance with the classification rules. None of the seven classification rules applies to the animal blood and serum products listed in Appendix 1.

As the animal blood and serum products are used as raw materials in manufacture and not as finished products for in vitro diagnosis of patients it will also not be possible to meet all the IVDR requirements for conformity assessment and performance evaluation.

For these reasons the products in Appendix 1 will no longer be classed as IVDs.

Considerations:

The removal of the CE and IVD symbols will have no impact on the manufacturing processes or quality of the products listed in Appendix 1; the change described is solely the removal of IVD status.

These products will continue to be suitable as raw materials for manufacture of IVDs.

TCS Biosciences will retain and maintain the ISO 9001:2015 quality management system, ISO 14001:2015 environmental management system and ISIA (International Serum Industry Association) Traceability Certification in accordance with current practices.

There is no impact on the issue of certificates of analysis for the products listed in Appendix 1.

Appendix 1
CCI 95 appendix 1

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Mar 2022

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 93

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 93

To: Customers purchasing Stain HD products

It is our intention to change the Manufacturing Process of the products listed below. The details of the change and the reason for it are given below.

Please acknowledge receipt of this notification and confirm your acceptance of the change by completing the section below and emailing a copy of the form to qc@tcsgroup.co.uk. Acceptance of the change is assumed if a response is not received within two weeks of issue of this notification.

If you have any difficulties or concerns accepting the change, please contact us immediately.

Product: Stain HD Dyes and Stains.

Product code: HD codes, HS codes, HDS codes, HK codes.

Proposed Change Date: 01 March 2022

Change Details:

Stain HD products may be provided in bottles of a larger size than usual.

Reason for Change:

Due to the Covid-19 pandemic the world-wide stocks of plastic products and the polymers used to produce these (including silica) are severely limited. Many bottle types used at TCS Biosciences are now on back[1]order with our suppliers and we anticipate our stocks of some bottles will run out before we receive our orders.

Considerations:

Any larger bottles used to package Stain HD products will be made of the same material as the bottle that is usually used. The volume of product contained within the bottle will be clearly indicated on the label.

Conclusion:

We reserve the right to package our Stain HD products in bottles normally used for larger volumes to ensure we can continue to provide these products to our customers. This is a temporary action and we will revert to using the usual bottles for Stain HD products as soon as we receive stocks from our suppliers.

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Mar 2022

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 82

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 82

To:  Customers and Distributors of StainHD product range

It is our intention to change the Manufacturing Process of the products listed below.  The details of the change and the reason for it are given below.

If you have any difficulties or concerns accepting the change, please contact us immediately.

Product: StainHD product range (see list overleaf)

Proposed Change Date: From 1 March 2022

Change Details:

We are discontinuing some of the products and/or pack sizes from our current catalogue of StainHD products.

Reason for Change:

Due to the on-going Covid-19 pandemic TCS Biosciences continues to focus our production activities on our core products.

We have further reviewed our range of StainHD products and identified those products and pack sizes that are slower selling.

Some products will be discontinued from the range and some other products will have fewer pack sizes available than currently.  See list below

Considerations

This change control is issued to give customers and distributors as much advance notice as possible prior to implementation of the change.

Until 1 March 2022 the products/pack sizes will continue to be available for sale while stocks last.

For your information, a certificate of analysis will be available for each product on our website https://www.tcsbiosciences.co.uk/dyesandstains/

Product / Pack sizes no longer available

Product code Product and pack size
HC product codes
HC2080-100 Karnowsky’s Fixative 100ml
HC5005-5L Citroclear 5L
HC8503 -1L Acetone 1L
HC8542-100 Berlese Fluid 100ml
HC8545-500 Bouin Fixative 500ml
HC8685-1L Glycerol-1L
HC8700-1 Gold chloride (brown)
HD product codes
HD1040-10 Alcian Blue 8GX 10g
HD1040-100 Alcian Blue 8GX 100g
HD1245-10 Chlroantine Fast Red 10g
HD1295-25 Crystal Violet
HD1320-100 Eosin Yellowish 100g
HD1410-25 Field’s Stain A (compound) 25g
HD1415-25 Field’s Stain B (compound) 25g
HD1525-100 Leishman Stain 100g
HD1715-25 Neutral Red 25g
HD1755-25 Orange G (acid orange 10) 25g
HD1760-10 Orcein (synthetic) 10g
HD1850-100 Safranin O 100g
HDS product codes
HDS05-100 Antigen Retrieval Buffer conc 100ml
HDS40/7.5-500 PBS Concentrate for Immuno 500ml
HS product codes
HS115-500 Alcian Blue 8GX (1% w/v aqueous) 500ml
HS140-500 Auramine Phenol (Lempert) 500ml
HS142-1L Auramine Phenol 10 x conc. 1L
HS165-100 Carbol Fuchsin (Gram) 10 x conc. 100ml
HS205 – 100 Cotton Blue – Lactophenol (Amann) 100ml
HS250-500 Eosin Y (1% aqueous) 500ml
HS255-500 Eosin Y (5% aqueous) 500ml
HS260-1L Eosin Y (1% alcoholic) 1L
HS280-250 Fuchsin Basic (sat. alco. soln.) 250ml
HS295-1L Giemsa Stain (modified) 1L
HS307-100 Gram’s Iodine 10 x conc 100ml
HS310-1L Gram’s Decolouriser 1L
HS315-500 Haemalum Mayer 500ml
HS345-500 Haematoxylin Gill 3 500ml
HS375-1L Haematoxylin Weigert Solution A 1L
HS380-500 Haematoxylin Weigert Solution B 500ml
HS390-1L Jenner Stain (modified) 1L
HS400-1L Leishman Stain 1L
HS405-500 Light Green (Masson) 500ml
HS430-1L Lugol’s Iodine 10 x conc. 1L
HS440-100 Malachite Green 10 x conc. 100ml
HS445-1L May Grunwald Stain (modified) 1L
HS500-250 Methylene Blue (1% w/v alcoholic) 250ml
HS500-500 Methylene Blue (1% w/v alcoholic) 500ml
HS520-100 Methylene Blue Polychrome 100ml
HS520-250 Methylene Blue Polychrome 250ml
HS555-500 Neutral Red (1% aqueous) 500ml
HS612-100 Orcein Solution (Shikata) 100ml
HS630-1L Papanicolaou Stain EA50 1L
HS635-1L Papanicolaou Stain OG6 1L
HS672-500 Potassium Permanganate (1% aq) 500ml
HS705-1L Rapid Romanowsky Stain Pack 3 x 1L
HS705A-2.5L Rapid Romanowsky Stain A 2.5L
HS705B-2.5L Rapid Romanowsky Stain B 2.5L
HS705C-2.5L Rapid Romanowsky Stain C 2.5L
HS762-100 Thiazine Red 10 x conc. 100ml
HS775-250 Trichrome Stain for Protozoa 250ml
HS776-250 Trichrome Stain for Microsporidia 250ml
HS785-1L Wright Stain (modified) 1L
HS785-500 Wright Stain (modified) 500ml
HS805-MB Cold ZN – Kinyoun Stain Pack 3 x 250ml

View Article

Dec 2021

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 81

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 81

To: Customers and Distributors of animal blood and serum products

It is our intention to change the status of the products listed below. The details of the change and the reason for it are given below.

Product: Animal Blood and Serum products – see Appendix 1 for full list of products and product codes

Proposed Change Date: 1 January 2022

Change Details:

These products will no longer be classed as in vitro diagnostic products (IVDs). The labels for these products will not include the CE or IVD symbols.

Reason for Change:

Currently the products listed in Appendix 1 are classified as IVDs in accordance with Annex Ill of Directive 98/79/EC and a self-declaration of conformity is available for each product.

Directive 98/79/EC is to be replaced by Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) for which the date of application is 26 May 2022.

It is a requirement of the IVDR to reclassify all IVDs in accordance with the classification rules. None of the seven classification rules applies to the animal blood and serum products listed in Appendix 1.

As the animal blood and serum products are used as raw materials in manufacture and not as finished products for in vitro diagnosis of patients it will also not be possible to meet all the IVDR requirements for conformity assessment and performance evaluation.

For these reasons the products in Appendix 1, below, will no longer be classed as IVDs.

Considerations

The removal of the CE and IVD symbols will have no impact on the manufacturing processes or quality of the products listed in Appendix 1; the change described is solely the removal of IVD status.

These products will continue to be suitable as raw materials for manufacture of IVDs.

TCS Biosciences will retain and maintain the ISO 9001:2015 quality management system, ISO 14001:2015 environmental management system and !SIA (International Serum Industry Association) Traceability Certification in accordance with current practices.

There is no impact on the issue of certificates of analysis for the products listed in Appendix 1.

APPENDIX 1:

Product Product codes
Bovine Blood in Alsever's OB0?AP
Bovine Blood Defibrinated BB003
Bovine Blood in Heparin BB-HEP-1 L
Chicken Blood Cells (Adult) in Alsever's FB010AP, FB011AP, FB012AP, FB013AP
Chicken Whole Blood in Alsever's 1:1 FB021AP
Chicken Whole Blood Defibrinated Non-Sterile FB022AP
Goat Blood in Alsever's OB026AP
Guinea Pig Blood Cells in Alsever's PB029AP,PB030AP,PB031AP,PB032AP
Whole Foal Blood in EDTA HB110
Mouse Blood in K2 EDTA MS011
Pig Blood Citrated Raw 2% Sodium Citrate PB003AP
Pig Whole Blood Sterile 9:1 Citrate Mixture PB002AP
Pig Blood in EDTA PB004AP
Rabbit Blood in Alsever's RB053AP, RB054AP, RB056AP
Rabbit Blood Defibrinated RB051AP, RB052AP,RB055AP
Rat Blood in EDTA (raw) OB122
Male Rat Blood in K2 EDTA OB115
Sheep Blood Buffy Coat Suspension SB117
Turkey Blood in Alsever's OB117AP
Turkey Cells in Alsever's OB118AP. OB119AP

View Article

Dec 2021

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 80

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 80

To:  Customers and Distributors of Selectrol

It is our intention to change the Manufacturing Process of the products listed below.  The details of the change and the reason for it are given below.

If you have any difficulties or concerns accepting the change, please contact us immediately.

Product: MM69 Candida glabrata NCPF 3309 / ATCC® 2001

Product code: MM69-10 (10 disc)

Proposed Change Date: January 2022

Change Details:

MM69 is going to become obsolete from the Selectrol product range. We estimate our current stocks will have sold out by Jan 2022.

Reason for Change:

NCPF are unable to supply this strain as Generation 0 (zero) in order for us to produce a 1st generation product in the form of Selectrol discs. There are no alternative strains of the same name available to use in replacement.

View Article

Dec 2021

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 70A

TCS BIOSCIENCES LTD, CHANGE NOTICE: CCI 70A

To: Customers and Distributors of StainHD product range.

It is our intention to change the Manufacturing Process of the products listed below.

The details of the change and the reason for it are given below.

If you have any difficulties or concerns accepting the change, please contact us immediately.

Product: StainHD product range (see list below)

Proposed Change Date: From 1 June 2021

Details: We are discontinuing some of the products and/or pack sizes from our current catalogue of StainHD products.

Reason for Change: Due to the current Covid-19 pandemic TCS Biosciences is focussing our production activities on our core products. We have reviewed our range of StainHD products and identified those products and pack sizes that are slower selling. Some products will be discontinued from the range and some other products will have fewer pack sizes available than currently. See list below Note – this list is not exhaustive and TCS Biosciences reserves the right to include further products as necessary.

Considerations: This change control is issued to give three months’ advance notice prior to implementation of the change. For your information, a certificate of analysis will be available for each product on our website https://www.tcsbiosciences.co.uk/dyesandstains/

Pack sizes no longer available:

  • HC6455-50 Periodic Acid (50% solution) 50ml
  • HC8610-100 DPX Mounting Medium 100ml
  • HC8715-50 Immersion Oil 50ml
  • HC8805-25 Silver Nitrate 25g
  • HD1295-10 Crystal Violet (CI42555) 10g
  • HD1295-25 Crystal Violet (CI42555) 25g
  • HD1320-25 Eosin Yellowish 25g
  • HD1410-1K Field’s Stain A (compound) 1kg
  • HD1415-1K Field’s Stain B (compound) 1kg
  • HD1715-10 Neutral Red 10g
  • HD1850-25 Safranin O 25g
  • HS115-250 Alcian Blue 8GX(1% w/v aqueous) 250ml
  • HS116-100 Alcian Blue 8GX(1% in 3% acetic acid) 100ml
  • HS116-250 Alcian Blue 8GX(1% in 3% acetic acid) 250ml
  • HS137-1L Potassium Permanganate (0.1% aqueous) 1L
  • HS140-1L Auramine Phenol (Lempert) 1L
  • HS140-250 Auramine Phenol (Lempert) 250ml
  • HS160-250 Carbol Fuchsin (Gram) 250ml
  • HS170-250 Carbol Fuchsin (Ziehl-Neelsen) 250ml
  • HS180-250 Carbol Fuchsin (Kinyoun) 250ml
  • HS200-100 Amyloid Stain Congo Red Solution 100ml
  • HS205-250 Cotton Blue – Lactophenol (Amann) 250ml
  • HS205-500 Cotton Blue – Lactophenol (Amann) 500ml
  • HS230-250 Crystal Violet (Gram) 250ml
  • HS232-250 Crystal Violet Oxalate (Gram) 250ml
  • HS280-100 Fuchsin Basic (sat. alco. soln.) 100ml
  • HS295-250 Giemsa Stain (modified) 250ml
  • HS305-250 Gram’s Iodine 250ml
  • HS310-250 Gram’s Decolouriser 250ml
  • HS315-100 Haemalum Mayer 100ml
  • HS356-100 Haematoxylin Harris (with acetic acid) 100ml
  • HS330-1L Haematoxylin Ehrlich 1L
  • HS375-250 Haematoxylin Weigert Solution A 250ml
  • HS380-250 Haematoxylin Weigert Solution B 250ml
  • HS425-250 Lugol’s Iodine 250ml
  • HS515-250 Methylene Blue Polychrome 250ml
  • HS555-100 Neutral Red (1% aqueous) 100ml
  • HS705A-1L Rapid Romanowsky Stain A 1L
  • HS720-250 Safranin (1% Aqueous) 250ml
  • HS780-100 Van Gieson Stain 100ml
  • HS787-1L ZN Decolouriser 1L
  • HS787-250 ZN Decolouriser 250ml
  • HC8695-500 Glycerin Jelly 500g
  • HC8700-1 Gold Chloride (brown) 1g
  • HC8855-5L Xylene 5L
  • HD1090-100 Aniline Blue Water Soluble 100g
  • HD1090-25 Aniline Blue Water Soluble 25g
  • HD1115-100 Auramine O 100g
  • HD1145-10 Azur II 10g
  • HD1175-25 Biebrich Scarlet 25g
  • HD1190-10 Brilliant Cresyl Blue 10g
  • HD1190-25 Brilliant Cresyl Blue 25g
  • HD1255-25 Chromatrope 2R – 25g
  • HD1270-10 Congo Red 10g
  • HD1270-100 Congo Red 100g
  • HD1290-10 Crystal Ponceau (acid red 44) 10g
  • HD1380-10 Fast Green FCF 10g
  • HD1380-25 Fast Green FCF 25g
  • HD1425-10 Fuchsin Acid 10g
  • HD1425-25 Fuchsin Acid 25g
  • HD1435-25 Fuchsin Basic for ZN 25g
  • HD1455-25 Giemsa Stain 25g
  • HD1475-100 Haematoxylin 100g
  • HD1475-25 Haematoxylin 25g
  • HD1570-25 Lugol Iodine (compound) 25g
  • HD1595-25 Martius Yellow 25g
  • HD1605-25 May Grunwald Stain 25g
  • HD1620-25 Methyl Blue 25g
  • HD1660-100 Methylene Blue Alkaline (Loeffler) 100g
  • HD1660-25 Methylene Blue Alkaline (Loeffler) 25g
  • HD1745-25 Nuclear Fast Red 25g
  • HD1755-100 Orange G (acid orange 10) 100g
  • HD1785-10 Ponceau Fuchsin (Masson) 10g
  • HD1785-25 Ponceau Fuchsin (Masson) 25g
  • HD1800-25 Ponceau de Xylidine 25g
  • HD1960-10 Toluidine Blue O (basic blue 17) 10g
  • HD1960-25 Toluidine Blue O (basic blue 17) 25g
  • HS145-1L Auramine Decolouriser (Lempert) 1L
  • HS172-1L Carazzi Stain 1L
  • HS570-250 Neutral Red (Jensen) 250ml
  • HS670-500 Ponceau Fuchsin (Masson) 500ml

View Article

Mar 2021

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