Luminex recalls Verigene Enteric Pathogens Nucleic Acid Test kits with specific cartridge model due to risk of false Yersinia enterocolitica results. Affected units include lot 032718023A.
Elevated false positive results Yersinia enterocolitica (Yersinia) from customers using the EP Nucleic Acid Test Cartridges component (20-006-023) from the Verigene EP Nucleic Acid Test Kit (20-005-023).
Luminex is recalling Verigene Enteric Pathogens Nucleic Acid Test kits that use certain cartridges. The recall is because these kits can give false positive results for Yersinia enterocolitica, a type of bacteria that can cause illness. This means the test might incorrectly show infection when there isn't one.
The test kit can produce false positive results for Yersinia enterocolitica, a bacterium that causes gastrointestinal illness. This means the test might indicate infection when there is none, leading to unnecessary treatment or anxiety. The false results are caused by the specific cartridge model used in the kit.
Individuals who purchased the Verigene EP Nucleic Acid Test Kit (20-005-023) with cartridge model 20-006-023. Those using the test for gastrointestinal infections are most at risk of false results.
Check for the kit catalog number 20-005-023 and cartridge catalog number 20-006-023. The affected lot number is 032718023A. The test is used for detecting pathogens in stool samples from people with gastrointestinal symptoms.
Verify the kit catalog number (20-005-023) and cartridge model (20-006-023) to confirm if your test is affected.
The recall is due to elevated false positive results for Yersinia enterocolitica from the specific cartridge model used in the test kit.
The official recall notice does not specify a remedy or action steps beyond checking if your kit is affected.
The test can produce false positive results for Yersinia enterocolitica, which may lead to unnecessary treatment or anxiety.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-2952-2018 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-2952-2018 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.
