Biomerieux recalls VITEK 2 AST-GN81 test kits due to potential performance issues from temperature and time exposure. Affected kits may not function correctly.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Biomerieux is recalling VITEK 2 AST-GN81 test kits because they might not work properly if exposed to incorrect temperatures or times. This could affect test results in medical labs.
The test kits may not function correctly if stored or used outside the recommended temperature and time ranges. This can lead to unreliable test results in medical settings.
Medical labs using the VITEK 2 AST-GN81 test kits with catalog number 413438 are likely affected. Lab technicians handling these kits are at risk of inaccurate test results.
Check for the catalog number 413438 on the kit packaging. The batch numbers 6712257403 and UDI/DI 03573026399030 are also associated with this recall.
Verify the catalog number 413438 and batch numbers 6712257403 on the kit packaging.
The test kits may not function correctly if exposed to temperatures or times outside the recommended range, leading to unreliable test results.
Look for the catalog number 413438 and batch numbers 6712257403 on the kit packaging.
The recall does not specify a remedy, so contact Biomerieux for further instructions.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0838-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0838-2023 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.
