Biomerieux recalls VITEK 2 reagent kits with potential performance issues due to temperature and time out of range. Affected kits may not work correctly.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Biomerieux is recalling VITEK 2 reagent test kits that may not perform correctly if the temperature or time settings are outside the required range. This could lead to inaccurate test results.
The reagent kits require specific temperature and time conditions to function properly. If these conditions are not met, the test results may be unreliable.
Laboratory users who purchased the VITEK 2 reagent kits with catalog number 21345 are affected. Those using the kits for medical testing may be at risk of inaccurate results.
Check for the catalog number 2134:5 on the kit packaging. The batch numbers listed are 2392195203. The kits were sold with UDI/DI 353026131951.
Verify the catalog number and batch numbers on the kit packaging to confirm if it is affected.
The recall is due to potential performance issues if the temperature or time settings are outside the required range.
Check for catalog number 21345 and batch number 2392195203 on the kit packaging.
The recall does not require immediate action, but you should check the kit details to ensure it is affected.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0790-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0790-2023 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.
