bioMerieux recalls VIDAS Lyme IgM II (LYM) tests with specific lot numbers due to substrate errors that may cause delayed results. Affected users should contact the manufacturer for guidance.
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 certain VIDAS Lyme IgM II (LYM) tests because a substrate error prevents the test from running, leading to potential delayed results. This could cause unnecessary retesting and delays in identifying Lyme disease.
The substrate error in the test prevents it from running correctly, so users must repeat the test. This can cause delays in getting results, potentially leading to unnecessary retesting and longer wait times for Lyme disease diagnosis.
People who purchased or use the recalled VIDAS Lyme IgM II (LYM) tests with specific lot numbers are affected. Those testing for Lyme disease are most at risk of delayed results.
Check the lot numbers on the test: 1008636750, 1008768920, or 1008857410. The product is labeled as VIDAS Lyme IgM II (LYM) with reference number REF 416436.
Identify the lot number on the test to see if it matches 1008636750, 1008768920, or 1008857410.
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 to see if it matches the recalled numbers. If it does, contact bioMerieux for guidance.
The recall record does not mention a specific remedy or fix for the substrate error.
We’ve drafted a message you can send bioMerieux to request your refund or repair — edit it as you like.
Subject: Recall Z-0436-2022 — bioMerieux bioMerieux Hello, I own a bioMerieux that is covered by recall Z-0436-2022 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.
