Biomerieux recalls VITEK 2 AST-N801 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-N801 test kits because they might not work properly if stored or used outside the recommended temperature and time range. This could affect test accuracy in medical labs.
The test kits may not function correctly if exposed to temperatures or time conditions outside the manufacturer's specifications. This could lead to inaccurate test results in medical settings.
Medical labs using the VITEK 2 AST-N801 test kits with catalog number 423416 are most likely affected. The risk is low as the issue relates to test performance rather than immediate safety hazards.
Check for the catalog number 423416 on the test kit packaging. The kits were sold with batch numbers starting with 412148504.
Look for the catalog number 423416 and batch numbers starting with 412148504 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 affect test accuracy.
Check for the catalog number 423416 and batch numbers starting with 412148504 on the test kit packaging.
The recall does not specify a remedy, so no action is required beyond checking if you have the affected kit.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0856-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0856-2023 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.
