Biomerieux recalls ETEST CLINICAL FLUCONAZOLE FL 256 US S30 (Catalog 412333) due to potential performance issues from temperature/time exposure. Affected units have 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 ETEST CLINICAL FLUCONAZOLE FL 256 US S30 test kits 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 incorrectly.
The test kits may not function correctly if stored or used outside the specified temperature and time ranges. This could result in inaccurate test results, but does not pose a direct physical hazard to users.
Healthcare professionals and labs using the ETEST CLINICAL FLUCONAZOLE FL 256 US S30 test kits with batch numbers starting from 1009172020 are most at risk. The recall affects specific units with the UDI/DI code 03573026377717.
Check for the product name 'ETEST CLINICAL FLUCONAZOLE FL 256 US S30' with catalog number 412333. Affected units have batch numbers starting with 1009172020 and UDI/DI code 03573026377717.
Verify the product name, catalog number, batch numbers, and UDI/DI code to confirm if your kit is affected.
No, the recall is for potential performance issues, not a direct safety hazard. The test kits may not work correctly if exposed to incorrect temperatures or times.
Check the product details to see if it matches the affected units. If it does, you may need to contact Biomerieux for further instructions.
Look for the product name 'ETEST CLINICAL FLUCONAZOLE FL 256 US S30', catalog number 412333, batch numbers starting with 1009172020, and UDI/DI code 03573026377717.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0824-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0824-2023 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.
