Biomerieux recalls VITEK 2 AST-GP67 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-GP67 test kits that may not work properly if stored or used outside recommended temperature and time conditions. This could lead to inaccurate test results.
The test kits may not perform correctly if exposed to temperatures or time periods outside the manufacturer's specifications. This could lead to inaccurate test results, but does not pose a direct safety risk to users.
Laboratory users who own or use the VITEK 2 AST-GP67 test kits with catalog number 22226. Those most at risk are users who store or handle the kits outside recommended temperature and time conditions.
Check for the catalog number 22226 on the test kit packaging. The kits were sold with batch numbers starting with 1322258403 and have a unique identifier 03573026242060.
Verify if the test kit has been stored or used outside recommended temperature and time conditions.
The test kits may not perform correctly if stored or used outside recommended temperature and time conditions.
Check if the kit has been stored or used outside recommended temperature and time conditions. If so, contact Biomerieux for guidance.
Look for catalog number 22226 on the packaging and batch numbers starting with 1322258403.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0792-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0792-2023 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.
