Luminex recalls specific Verigene Enteric Pathogens Nucleic Acid Test kits that may give false-negative results due to hydrophobic FLOQSwab lots. Affected units include certain lot numbers from 2022-2023.
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 specific batches of Verigene Enteric Pathogens Nucleic Acid Test kits that could produce false-negative results in rare cases. This means the test might incorrectly show no infection when one exists, potentially leading to missed diagnoses.
The test kits use FLOQSwab strips that, in rare instances, have hydrophobic characteristics that can cause false-negative results. This means the test might fail to detect infections when they're actually present, leading to missed diagnoses.
People who own or use the Verigene Enteric Pathogens Nucleic Acid Test kits with the listed lot numbers are affected. Those testing for infections in high-risk situations (like food safety or clinical settings) are most at risk.
Check the lot number on the test kit packaging. Affected lots include specific numbers from 2022-2023 listed in the recall notice, such as 071322023D, 071822023B, and others.
Look for the lot number on the test kit packaging to determine if it's affected.
The recall is for specific lots of Verigene Enteric Pathogens Nucleic Acid Test kits that may provide false-negative results due to hydrophobic characteristics in the FLOQSwab strips.
Check the lot number on the test kit packaging. Affected lots include specific numbers from 2022-2023 listed in the recall notice.
The recall does not specify a remedy, so affected users should check with Luminex Corporation for guidance.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-2023-2023 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-2023-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
