bioMerieux recalls VIDAS Lyme IgG II (LYM) tests with a substrate error that prevents proper testing, causing potential delayed results. Affected units have specific lot numbers.
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 Lyme IgG II (LYM) tests that may not run correctly due to a substrate error, leading to potential delayed results. This affects users who need accurate Lyme disease testing.
The test substrate error prevents the test from running properly. This means users must repeat the test, potentially delaying results and causing uncertainty about Lyme disease status.
Users of VIDAS Lyme IgG II (LYM) tests with specific lot numbers are affected. People needing Lyme disease testing are most at risk of delayed results.
Check for the lot numbers 1008714880 or 1008824220 on the test packaging. The product is identified by the reference number REF 417401.
Look for lot numbers 1008714880 or 1008824220 on the test packaging.
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 packaging. If it matches 1008714880 or 1008824220, contact bioMerieux for guidance.
The recall record does not mention a fix or remedy 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-0437-2022 — bioMerieux bioMerieux Hello, I own a bioMerieux that is covered by recall Z-0437-2022 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.
