Biomerieux recalls 60-test progesterone kits (catalog 304:09-01) due to temperature sensitivity causing unreliable results. Affected units may need replacement.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Biomerieux is recalling 60-test progesterone kits that may not work properly if exposed to temperatures outside the recommended range. This could lead to inaccurate test results if used without proper conditions.
The tests may not function correctly if stored or used outside the required temperature range. This can cause unreliable results, but does not pose a direct physical risk to users.
Users of the VIDAS Progesterone 60-Test kits (catalog 30409-01) who have the specific batch numbers listed. Healthcare providers and labs using these kits are most at risk.
Check for the catalog number 30409-01 on the kit box. The batch numbers 1009375960 are affected. The kits were sold with UDI/DI 03573026156954.
Verify the catalog number (30409-01) and batch number (1009375960) on the kit box.
No, but you should check if your kit has the affected batch number before use.
The tests may not work properly, leading to inaccurate results.
Check the catalog number (30409-01) and batch number (1009375960) on the kit box.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0866-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0866-2023 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.
