Biomerieux recalls 20-plate Candida test kits with potential temperature issues that may affect test accuracy. Affected units have specific batch numbers and catalog codes.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Biomerieux is recalling clinical Candida test plates that may not work properly if exposed to temperatures outside the recommended range. This could lead to inaccurate test results if used without proper temperature control.
The test plates may not function correctly if temperatures go outside the specified range. This could lead to inaccurate test results, potentially affecting diagnosis and treatment decisions for Candida infections.
Users of the Biomerieux PPM Clinical Chromid Candida 20-plate test kits with batch numbers 1009532350 or catalog number 43631 are affected. Laboratory staff and healthcare providers using these kits for Candida testing are most at risk.
Check for the catalog number 43631 and batch number 1009532350 on the product label. The product is sold under the brand name Biomerieux.
Look for the catalog number 43631 and batch number 1009532350 on the product label.
The product may not work correctly if temperatures go outside the recommended range, which could lead to inaccurate test results.
Check for the catalog number 43631 and batch number 1009532350 on the product label.
The recall 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-0801-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0801-2023 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.
