Biomerieux recalls VITEK 2 AST-GN73 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-GN73 test kits because they might not work properly if stored or used outside the recommended temperature and time range. This could lead to inaccurate test results.
The test kits may not perform correctly if the temperature or time outside the recommended range is exceeded. This could result in inaccurate test results, but does not pose a direct safety risk to users.
Users of the VITEK 2 AST-GN73 test kits, particularly those in labs or clinical settings that rely on these kits for testing. Those who have the specific kit model and batch numbers listed are most at risk.
Check for the product name 'VITEK 2 REAGENT AST-GN73 TEST KIT 20 CARDS' with catalog number 413404. Affected kits have UDI/DI 03573026398507 and batch numbers starting with 5932237403.
Verify the product name, catalog number, and batch numbers to confirm if your kit is affected.
The test kits may not work correctly if stored or used outside the recommended temperature and time range, which could lead to inaccurate test results.
Check the product details to confirm if your kit is affected. If it is, you may need to contact Biomerieux for further instructions.
No, the recall is for potential inaccurate test results, not a direct safety hazard.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0835-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0835-2023 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.
