Luminex recalls specific VERIGENE Enteric Pathogens Nucleic Acid Test kits that may produce false negative results due to swab hydrophobic characteristics. Affected kits include certain Luminex and FLOQSwab lot numbers.
There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.
Luminex is recalling specific versions of their VERIGENE Enteric Pathogens Nucleic Acid Test kits because the swabs used in these tests can cause false negative results. This means the test might not detect infections when they are actually present, which could lead to missed diagnoses.
The swabs in these kits have hydrophobic characteristics that can cause false negative results. This means the test might not detect infections when they are actually present, potentially leading to missed diagnoses of enteric pathogens.
People who purchased the recalled VERIGENE Enteric Pathogens Nucleic Acid Test kits with the specific Luminex lot numbers and FLOQSwab lot numbers listed in the recall are affected. Those who use these tests for stool sample analysis for enteric pathogens are most at risk of missing infections.
Check the Luminex lot number on the test kit and the FLOQSwab lot number. Affected kits include specific combinations like Luminex Lot 030121023A with FLOQSwab Lot 2100856, among others listed in the recall.
Look for the Luminex lot number and FLOQSwab lot number on the test kit packaging. If they match the affected combinations listed in the recall, the kit is recalled.
The recall is because the swabs in these kits have hydrophobic characteristics that can cause false negative results, meaning infections might not be detected.
Check the Luminex and FLOQSwab lot numbers on your kit. If they match the affected combinations listed in the recall, you should stop using it and contact Luminex for instructions.
No, the recall is for potential false negative results, not a physical hazard. There is no risk of injury from using the test.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-1335-2022 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-1335-2022 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.
