Biomerieux recalls PREVI COLOR GRAM Reagent Iodine-B (NA) due to potential performance issues from temperature and time out of range. Affected units include specific batch numbers and catalog codes.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Biomerieux is recalling PREVI COLOR GRAM Reagent Iod:ine-B (NA) because it may not work properly if stored or used outside recommended temperature and time ranges. This could affect test accuracy in medical settings.
The reagent may not perform correctly if stored or used outside the manufacturer's specified temperature and time ranges. This could lead to inaccurate test results in medical settings.
Medical labs and healthcare facilities that use this reagent for testing may be affected. Users most at risk are those relying on the reagent for critical diagnostic tests.
Check for the catalog number 29586 and batch numbers 230438 on the reagent container. The product was sold with a unique identifier (UDI/DI) 03573026263140.
Identify the catalog number 29586 and batch number 230438 on the reagent container.
The recall states that the reagent may not perform correctly if stored or used outside recommended temperature and time ranges, but it does not indicate immediate danger to users.
The recall does not specify a remedy, so no action is required beyond checking the product details for the affected batch numbers.
Check for the catalog number 29586 and batch number 230438 on the reagent container, as well as the unique identifier (UDI/DI) 03573026263140.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0793-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0793-2023 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.
