Biomerieux recalls API NIT1 NIT2 reagents (catalog 704:442) due to temperature and time issues affecting performance. Affected units include 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 API NIT1 and NIT2 reagents because they may not work properly if stored outside the recommended temperature and time range. This could lead to inaccurate test results.
The reagents may not perform correctly if stored outside the required temperature and time range. This can cause inaccurate test results, but does not pose a direct physical danger.
Users of these reagents for laboratory testing are affected. Those who have the specific batch numbers or UDI/DI codes listed are most at risk.
Check for the catalog number 70442 on the reagent packaging. Look for the UDI/DI code 03573026099671 and batch numbers starting with 1009326520.
Review the reagent packaging for the catalog number 70442, UDI/DI code 03573026099671, and batch numbers starting with 1009326520.
The reagents may not work properly if stored outside the recommended temperature and time range, leading to inaccurate test results.
Check the packaging for the catalog number 70442, UDI/DI code 03573026099671, and batch numbers starting with 1009326520. If you have these, contact Biomerieux for guidance.
The recall record does not mention a specific remedy or fix for this issue.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0809-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0809-2023 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.
