Medical device manufacturer, bioMerieux, has issued a medical device safety alert concerning its CHOCOLATE POLYVITEX [Product Description: A) CHOCOLATE POLYVITEX 100 BTE; B) CHOCOLATE POLYVITEX 20 BTE; Reference Number: A) 43109; B) 43101].

Based on complaints regarding a low or lack of growth of S. aureus strains and Corynebacterium striatum strain on CHOCOLATE POLYVITEX 100PLATES (Reference: 43109, Lot: 1008049150), the manufacturer initiated a complaint investigation to confirm product issue and determine root cause.

The following have been identified by the manufacturer:

• The issue was confirmed for 5 out of 13 of the lots tested available on the market in date of investigation, the manufacturer observed no or low growth of some ATCC Staphylococci strains (ATCC 29213, ATCC 6538, ATCC 29971), Staphylococcus strains from patient isolates and Corynebacterium diphteriae ATCC 27010 depending on the lot.
• The issue is localized on a part of each lot concerned corresponding to 1/4 of each lot.
• S. aureus ATCC 29213 is part of the final Quality Control testing and results were within the specifications at release, therefore issue seems to appear over the product shelf-life.
• On lots for which the issue was confirmed, the manufacturer observed a good growth of the fastidious Quality Control release strains: Neisseria gonorrhoeae ATCC 43069, Neisseria gonorrhoeae ATCC 49226, Neisseria meningitides ATCC 13090, Haemophilus influenzae ATCC 10211, Streptococcus pneumoniae ATCC 6305, Candida albicans ATCC 60193.
• Therefore, this issue seems not related to a specific lot but only to a specific part of each lot. Also, the issue could appear over the product shelf-life, then the manufacturer cannot exclude that all lots of the product references listed could be impacted.

Based on the investigation results, there is a potential risk of false negative results for Staphylococci and Corynebacterium species when using CHOCOLATE POLYVITEX (Reference: 43109 and 43101).

Affected users should distribute this information to all appropriate personnel in their laboratories. The intended use of the impacted product references is to detect fastidious bacteria belonging to Neisseria,Haemophilus and Streptococcus pneumonia and for other strains, affected users are required to perform systematically in addition to a non-selective media (For example: Columbia agar + 5% sheep blood).

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 18 August 2020