Selectrol Certificates

[Jonelle Rycroft]

NoteSelectrol 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.

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.

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.

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.

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.

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.

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

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).

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'.

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 q...@tcsgroup.co.uk. Acceptance of the change is assumed if a response is not received within two weeks of issue of this notification.

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.

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.

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.

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.

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.

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.

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: 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.

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.

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.

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.

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 q...@tcsgroup.co.uk. Acceptance of the change is assumed if a response is not received within two weeks of issue of this notification.

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.

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.

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.

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.

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.

Cost reductionAs your system partner, we actively help you to reduce your costs:

We comply with all requirements of ISO 11133, ISO 13485 and Ph. Eur. to the manufacturing, quality control and performance testing of our ready to use diagnostic culture media. You benefit, as work-intensive quality testing of incoming media is no longer necessary, remaining at a constant quality-level.We offer individual reservations for whole batches according to your requirements and to your demands. Your cost for quality controls will be reduced because a new delivery of media does not necessarily lead to a new batch.We consistently control the storing conditions of our ready to use media from the manufacturing until the delivery to your laboratory. You save additional transport validation and documentation.We test the combinations of your ready to use media and the membrane filters that are used in your laboraroty according to ISO 11133 and ISO 7704. You will receive individual quality control certificates. You receive a product which is individually tested and certified for you and that is based on your individual needs.Our Xebios-App guarantees a clear presentation of your inventory, consumptions, stock and demands for your diagnostic culture media. We archive and adminstrate all quality certificates (product, filter, transport) for you, to significantly reduce paper work in your laboratory.

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