Biomerieux recalls GENE-UP Salmonella 2 reagent 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 GENE-UP Salmonella 2 reagent because it may not work properly if stored or used outside the correct temperature and time range. This could lead to inaccurate test results.
The reagent may not perform correctly if stored or used outside the specified temperature and time range. This could result in inaccurate test results, potentially affecting diagnosis or treatment decisions.
Users of the GENE-UP Salmonella 2 reagent who purchased it with catalog number 423105 are affected. Laboratory staff and healthcare professionals using this reagent for testing are most at risk.
Check for the catalog number 423105 on the reagent label. Affected units have batch numbers starting with 1009407250 and UDI/DI code 03573026608514.
Verify the catalog number and batch number on the reagent label to confirm if it is affected.
The reagent may not perform correctly if stored or used outside the specified temperature and time range, which could lead to inaccurate test results.
Check the catalog number and batch number on the label to see if it is affected. If it is, you may need to contact Biomerieux for further instructions.
The recall is for potential performance issues, not a risk of serious injury. The danger level is low risk.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0855-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0855-2023 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.