Biomerieux recalls VITEK 2 AST-GN80 test kits due to potential performance issues from temperature/time exposure. Affected kits may not function correctly after being stored outside recommended conditions.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Biomerieux is recalling VITEK 2 AST-GN80 test kits that may not work properly if stored outside the recommended temperature and time range. This could affect test accuracy in medical labs using these kits.
The test kits may not perform correctly if stored outside the manufacturer's temperature and time specifications. This could lead to inaccurate test results in medical settings.
Medical labs using the VITEK 2 AST-GN80 test kits with catalog number 413437 are most at risk. The recall affects kits sold with specific batch numbers and UDI/DI codes.
Check for the catalog number 413437 on the kit packaging. Affected kits have UDI/DI code 03573026399023 and batch numbers starting with 6702239503.
Verify the catalog number 413437 and UDI/DI code 03573026399023 on the kit packaging.
The test kits may not perform correctly if stored outside the manufacturer's temperature and time specifications.
The recall record does not specify a remedy, so no action is required beyond checking if you have the affected kit.
Check for catalog number 413437, UDI/DI code 03573026399023, and batch numbers starting with 6702239503.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0837-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0837-2023 from Biomerieux. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
