Biomerieux recalls VIDAS RUB IGG 60 Tests (Catalog 30226) due to potential performance issues from temperature and time exposure. 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 VIDAS RUB IGG 60 Tests (Catalog 302:226) because they may not work properly if exposed to temperatures or times outside the recommended range. This could lead to inaccurate test results.
The tests may not function correctly if stored or used outside the recommended temperature and time ranges. This can cause inaccurate results, but does not pose a direct physical danger to users.
Lab users who own or use the VIDAS RUB IGG 60 Tests with the specific catalog number and batch numbers listed. Those most at risk are laboratory technicians handling these tests.
Check for the catalog number 30226 and batch numbers 1009370850 on the product label. Also look for the UDI/DI code 03573026138585.
Verify the catalog number 30226 and batch number 1009370850 on the test kit.
The tests may not work properly if exposed to temperatures or times outside the recommended range, leading to inaccurate results.
Check the product label for the catalog number 30226 and batch number 1009370850. If you have these, contact Biomerieux for further instructions.
No, the recall is for potential inaccurate test results, not physical injury risks.
We’ve drafted a message you can send Biomerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0797-2023 — Biomerieux Biomerieux Hello, I own a Biomerieux that is covered by recall Z-0797-2023 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.
