Biomerieux recalls VIDAS Estradiol II 60-Test Kits (Catalog 30431-01) due to potential performance issues from temperature/time exposure. Affected units include specific batch numbers and UDI/DI codes.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Biomerieux is recalling VIDAS Estradiol II : 60-Test Kits (Catalog 30431-01) because they may not work properly if exposed to temperatures or times outside the recommended range. This could lead to inaccurate test results if used without proper conditions.
The test kits may not function correctly if stored or used outside the specified temperature and time ranges. This could result in inaccurate hormone test results, potentially affecting medical decisions.
Users of the VIDAS Estradiol II 60-Test Kits (Catalog 30431-01) with specific batch numbers or UDI/DI codes are affected. Laboratory staff and healthcare providers using these kits for hormone testing are most at risk.
Check for the catalog number 30431-01 on the kit packaging. Affected units have UDI/DI code 03573026161637 and batch numbers starting with 1009378680.
Verify the catalog number and UDI/DI code on the kit packaging to confirm if it is affected.
The test kits may not work properly if exposed to temperatures or times outside the recommended range, leading to potential inaccurate results.
Check for the catalog number 30431-01 and UDI/DI code 03573026161637 with batch numbers starting with 1009378680.
The recall record does not specify a remedy, so contact Biomerieux directly for guidance.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0867-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0867-2023 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.
