News and Events

TCS Biosciences is pleased to announce a new Selectrol^® strain, MM49 Candida auris NCPF^® 8977, which is due to be available early 2025.

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Selectrol^® is a fully traceable and cost effective range of first generation Quality Control micro-organisms which have predictable biochemical reactions, making it ideal for a variety of quality control and testing applications.

• Quality control of culture media, staining reactions, biochemical profiling.
• Determination of antibiotic concentrations in blood, serum or CSF samples.
• Antibiotic susceptibility testing controls, whether by disc diffusion or serial dilution.

Selectrol^® discs are manufactured under license from UK Health Security Agency.

NCTC^® and NCPF^® are trademarks of UK Health Security Agency.
ATCC^® strains are listed for reference only.
ATCC^® is a registered trademark of the American Type Culture Collection.

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This strain has been noted to have three equivalent ATCC^® strains:

• ATCC^® 9634
• ATCC^® 11778
• ATCC^® 19637

All ATCC^® references listed above are equivalent to NCTC^® 10320.

It is not possible to list all ATCC^® numbers on the Selectrol^® label so only ATCC^® 9634 is indicated.

This information has been verified on the reference websites for NCTC^® and ATCC^®.

Note: Selectrol^® Discs are first generation freeze-dried microorganisms manufactured exclusively from NCTC^® (National Collection of Type Cultures) and NCPF^® (National Collection of Pathogenic Fungi) cultures and ATCC^® numbers are for reference only.

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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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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.

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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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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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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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:

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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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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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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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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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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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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.

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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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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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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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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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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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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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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

• View Full Change Notice CCI 95

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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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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

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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:

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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 1^st generation product in the form of Selectrol discs. There are no alternative strains of the same name available to use in replacement.

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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/

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