bioMerieux recalls VIDAS TOXO IgG Avidity (TXGA) tests with a substrate error that may cause delayed results. Affected units have UDI 03573026263010 and Lot #1008861590.
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 TOXO IgG Avidity (TXGA) tests that have a substrate error. This error prevents the test from running correctly, which may lead to delayed results and the need to repeat the test.
The substrate error prevents the test from running properly. This means users must run another test, which can delay results and potentially lead to repeated testing.
Users of VIDAS TOXO IgG Avidity (TXGA) tests with UDI 03573026263010 and Lot #1008861590 are affected. Laboratory staff and healthcare providers who use these tests are most at risk.
Check for the UDI 03573026263010 and Lot #1008861590 on the test kit. The affected product is VIDAS TOXO IgG Avidity (TXGA) with reference number 30222-01.
Look for the UDI 03573026263010 and Lot #1008861590 on the test kit.
bioMerieux has received complaints about a substrate error that prevents the test from running correctly, leading to potential delayed results.
Check the test kit for the UDI 03573026263010 and Lot #1008861590. If you have these details, contact bioMerieux for guidance.
No, the recall is for a technical error that may cause delayed results, not a safety hazard.
We’ve drafted a message you can send bioMerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0431-2022 — bioMerieux bioMerieux Hello, I own a bioMerieux that is covered by recall Z-0431-2022 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.
