bioMerieux recalls VIDAS RUB IgG (RBG) tests with specific lot numbers for potential delayed results due to a substrate error that prevents proper testing.
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
bioMerieux is recalling VIDAS RUB IgG (RBG) tests with certain lot numbers because a substrate error can cause the test to fail, requiring users to run another test and delaying results.
The substrate error prevents the test from running correctly, which means users must repeat the test and could delay results. This may lead to potential delays in diagnosis or treatment for patients.
Users of VIDAS RUB IgG (RBG) tests with lot numbers 1008694980, 1008700260, or 1008828980 are affected. Laboratory staff and healthcare providers who use these tests are most at risk.
Check the lot number on the test packaging. The affected lots are 1008694980, 1008700260, and 1008828980. The product is sold under the VIDAS RUB IgG (RBG) name with reference number 30226.
Look for the lot number on the test packaging to determine if it is affected.
bioMerieux has received complaints about a substrate error that prevents the test from running, leading to potential delayed results.
Check the lot number on the test packaging. If it matches the affected lots (1008694980, 1008700260, or 1008828980), you may need to run another test to avoid delayed results.
The recall does not provide a specific fix; users must run another test if the affected lot is used.
We’ve drafted a message you can send bioMerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0432-2022 — bioMerieux bioMerieux Hello, I own a bioMerieux that is covered by recall Z-0432-2022 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.
