Biomerieux recalls VITEK 2 GP test kits due to potential performance issues from temperature and time out of range. Affected kits may not work correctly.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Biomerieux is recalling VITEK 2 GP test kits because they might 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 stored or used outside the specified temperature and time ranges. This can cause inaccurate test results, which might affect diagnosis and treatment decisions.
Users of the VITEK 2 GP test kits for laboratory testing are affected. Lab technicians and healthcare providers who use these kits are most at risk of inaccurate results.
Check for the product name 'VITEK 2 REAGENT GP TEST KIT VTK2 2:20 CARDS' with catalog number 21342. The kit has specific batch numbers: 2422281503 and 2422288503.
Verify the catalog number (21342) and batch numbers (2422281503, 2422288503) to confirm if your kit is affected.
The recall is due to potential performance issues if the kit is stored or used outside the recommended temperature and time ranges.
Check for the product name 'VITEK 2 REAGENT GP TEST KIT VTK2 20 CARDS' with catalog number 21342 and batch numbers 2422281503 or 2422288503.
The recall does not specify a remedy, so contact Biomerieux for guidance on next steps.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0788-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0788-2023 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.
