Biomerieux recalls VITEK 2 AST-GN69 test kits due to temperature and time exposure affecting performance. No remedy stated in official notice.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Biomerieux is recalling VITEK 2 AST-GN69 test kits because they may not work properly if stored or used outside recommended temperature and time ranges. This affects lab testing accuracy but does not pose immediate safety risks.
The test kits may not function correctly if stored or used outside the manufacturer's specified temperature and time ranges. This could lead to inaccurate test results, but does not cause physical harm or injury.
Lab technicians and healthcare facilities using the VITEK 2 AST-GN69 test kits. Those most at risk are users who rely on these kits for accurate diagnostic testing.
Check for the product name 'VITEK 2 REAGENT AST-GN69 TEST KIT 20 CARDS' with catalog number 413400. Batch numbers include 5892256103.
Verify the product name, catalog number, and batch numbers listed in the recall notice.
The official recall notice does not mention any remedy or fix for this issue.
Look for the product name 'VITEK 2 REAGENT AST-GN69 TEST KIT 20 CARDS' with catalog number 413400 and batch number 5892256103.
No immediate action is required; the recall is about potential performance issues, not safety risks.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0833-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0833-2023 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.
