Luminex recalls Verigene C. diff test kits with model numbers 20-006-022, 041520022A, 061920022A, and 081120022A due to potential false negatives. Consumers should check their kit model and contact Luminex for details.
Potential for a false-negative result.
Luminex is recalling specific versions of their Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) because they may give false negative results. This means the test might incorrectly show no infection when it's actually present, which could lead to missed treatment.
The test may produce false negative results, meaning it could show no infection when the person actually has Clostridium difficile. This could lead to untreated infections, which are serious but not immediately life-threatening.
People who own or use the recalled Verigene C. diff test kits with model numbers 20-006-022, 041520022A, 061920022A, or 081120022A are affected. Healthcare providers and individuals testing for C. diff infections are most at risk.
Check the model number on the test kit, which should be one of 20-006-022, 041520022A, 061920022A, or 081120022A. The recall covers specific versions sold by Luminex.
Look for the model number on the test kit packaging or label to see if it matches the recalled versions: 20-006-022, 041520022A, 061920022A, or 081120022A.
No, the recall does not require stopping use. The test may give false negatives, but users should check their model number and contact Luminex for further guidance.
Contact Luminex directly to confirm your model and get instructions on next steps. They may provide a replacement or alternative testing options.
The test kit is safe to use, but there is a risk of false negative results. Using the correct model and following instructions can help ensure accurate results.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-2010-2021 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-2010-2021 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.
