Luminex recalls specific VERIGENE C. diff test kits that may give false negative results due to hydrophobic characteristics in certain FLOQSwab lots. Affected kits have lot numbers 071222022D and 100622022D.
It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic characteristics in specific FLOQSwab lots.
Luminex is recalling two specific VERIGENE Clostridium difficile Nucleic Acid Test kits that could give false negative results in rare cases. This means the test might incorrectly show no infection when it's actually present, which could lead to missing a serious health issue.
The test kits contain FLOQSwab lots with hydrophobic characteristics that can cause rare false negative results. This means the test might show no infection when the person actually has Clostridium difficile, potentially leading to untreated infections.
People who use the VERIGENE C. diff test kits with lot numbers 071222022D or 100622022D are affected. Those who rely on these tests for accurate diagnosis are most at risk of missing a potential infection.
Check the lot number on the test kit packaging. Affected kits have lot numbers 071222022D or 100622022D. The product is sold under the VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022.
Look for lot numbers 071222022D or 100622022D on the test kit packaging.
The test kits may give false negative results in rare instances due to hydrophobic characteristics in specific FLOQSwab lots.
Lot numbers 071222022D and 100622022D.
No, but you should check the lot number to ensure you have an unaffected kit.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-2024-2023 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-2024-2023 from Luminex. 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.
