Biomerieux recalls VIDAS Procalcitonin 60T test kits due to temperature and time issues potentially affecting test accuracy. 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 VIDAS Procalcitonin 60T test kits because they may not work properly if stored outside the recommended temperature and time range. This could lead to inaccurate test results if used incorrectly.
The test kits may not function correctly if stored outside the recommended temperature and time range. This can cause inaccurate test results, which might affect clinical decisions.
Healthcare professionals using the VIDAS Procalcitonin 60T test kits for clinical testing are likely affected. Those who have the specific batch numbers or UDI/DI codes listed are at risk of inaccurate results.
Check for the product name 'VIDAS CLINICAL VIDAS BRAHMS PROCALCITONIN 60T' with catalog number 30450-01. Affected units have batch numbers starting with 1009301530 and UDI/DI code 03573026223601.
Verify the product name, catalog number, and batch numbers listed in the recall notice to confirm if your kit is affected.
The product may not work properly if stored outside the recommended temperature and time range, potentially leading to inaccurate test results.
Check for the product name 'VIDAS CLINICAL VIDAS BRAHMS PROCALCITONIN 60T' with catalog number 30450-01 and batch numbers starting with 1009301530.
The recall notice does not specify a remedy, so contact Biomerieux for further instructions.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0868-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0868-2023 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.