Biomerieux recalls VITEK 2 GN test kits with potential performance issues due to temperature and time out of range. Affected kits may not work properly if stored or used incorrectly.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Biomerieux is recalling VITEK :2 GN test kits that may not perform correctly if stored or used outside recommended temperature and time ranges. This could lead to inaccurate test results.
The test kits may not function properly 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 GN test kits for laboratory testing are affected. Lab technicians and healthcare professionals using these kits are most at risk of inaccurate results.
Check for the VITEK 2 REAGENT GN TEST KIT VTK2 20 CARDS with catalog number 21341. Affected kits have batch numbers 2412101403, 2412103403, 2412103503, or 2412106403.
Verify the catalog number and batch numbers 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 the catalog number and batch numbers to see if your kit is 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-0787-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0787-2023 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.
