Biomerieux recalls VITEK 2 AST-GN95 test kits due to potential performance issues from temperature and time exposure. Affected kits have specific catalog and batch numbers.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Biomerieux is recalling VITEK 2 AST-GN95 test kits because they may not work properly if stored or used outside recommended temperature and time ranges. This could lead to inaccurate test results.
The test kits may not function correctly if exposed to temperatures or time periods outside the manufacturer's specified range. This could result in inaccurate test results, which might affect medical diagnoses.
Users of the VITEK 2 AST-GN95 test kits with catalog number 421982 and batch numbers starting with 6852245503 are affected. Laboratory users and healthcare professionals who rely on these test kits are most at risk.
Check for catalog number 421982 and batch numbers starting with 6852245503 on the kit packaging. The kits were sold with UDI/DI 03573026565923.
Verify the catalog number 421982 and batch numbers starting with 6852245503 on the test kit packaging.
The test kits may not work properly if stored or used outside the recommended temperature and time ranges, which could lead to inaccurate test results.
Check the catalog number and batch numbers on the packaging to see if it is affected. No specific action is required beyond verification.
The recall addresses potential inaccurate test results, not direct safety hazards. There is no risk of serious injury from this product.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0853-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0853-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
