Biomerieux recalls VITEK 2 AST-GN79 test kits due to potential performance issues from temperature and time exposure. Affected kits may not work correctly if stored or used outside recommended conditions.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Biomerieux is recalling VITEK 2 AST-GN79 test kits because they might not work properly if stored or used outside the correct temperature and time range. This could lead to inaccurate test results.
The test kits may not perform correctly if exposed to temperatures or time periods outside the manufacturer's specified range. This can happen if the kits are stored or used in conditions that don't match the recommended guidelines.
Laboratory users who own or use the VITEK 2 AST-GN79 test kits with catalog number 413436 are affected. Those handling the kits in clinical settings are most at risk of inaccurate test results.
Check for the catalog number 413436 on the test kit packaging. The batch numbers 5992201403 and 5992253503 are also associated with this recall.
Look for the catalog number 413436 and batch numbers 5992201403 or 5992253503 on the test kit packaging.
The test kits may not work correctly if stored or used outside the recommended temperature and time range, which could lead to inaccurate test results.
Check the catalog number and batch numbers on the packaging to see if it's affected. If it is, you may need to contact Biomerieux for guidance.
The recall record does not mention a specific remedy or fix for this issue.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0836-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0836-2023 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.
