Biomerieux recalls VITEK 2 AST-GP75 test kits due to temperature and time issues potentially affecting test accuracy. Affected kits have specific catalog and batch numbers.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Biomerieux is recalling VITEK 2 AST-GP75 test kits because they may not work properly if stored or used outside recommended temperature and time ranges. This could lead to inaccurate test results.
The test kits require specific temperature and time conditions to function correctly. If these conditions are exceeded, the product may not perform as intended, leading to inaccurate test results.
Users of the VITEK 2 AST-GP75 test kits who store or use them outside recommended temperature and time conditions. Laboratory staff handling these kits are most at risk of inaccurate test results.
Check for the catalog number 415670 and batch numbers starting with 2752252403 on the kit packaging. The kits were sold with UDI/DI 03573026437183.
Verify the kit's temperature and time conditions are within the manufacturer's specifications before use.
The test kits may not perform correctly if stored or used outside recommended temperature and time ranges, potentially leading to inaccurate test results.
Check if your kit's temperature and time conditions are within specifications. If not, contact Biomerieux for guidance.
Look for catalog number 415670 and batch numbers starting with 2752252403 on the kit packaging.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0843-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0843-2023 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.
