Lower riskMedical device recall · FDA · Published May 8, 2018
Luminex Verigene EP Test Kit Recall: False Yersinia Results Risk
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. Read more at govinfonow.com/recall/71166-luminex-verigene-ep-test-kit-recall-false-yersinia-results-risk.
“Luminex Verigene EP Test Kit Recall: False Yersinia Results Risk.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71166-luminex-verigene-ep-test-kit-recall-false-yersinia-results-risk. Based on FDA recall #Z-2952-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2952-2018%22&limit=1).
The FDA announced on May 8, 2018, that Luminex Corporation voluntarily recalled the Verigene Enteric Pathogens Nucleic Acid Test (EP) due to elevated false positive results for Yersinia enterocolitica. The agency issued recall number Z-2952-2018 for the device.
How to tell if you have it
Brand: Luminex
Product: Verigene Enteric Pathogens Nucleic Acid Test (EP)
Kit Catalog Number: 20-005-023
Cartridge Catalog Number: 20-006-023
Lot Code: 032718023A
UDI: 00857573006041
The hazard
According to the FDA, customers using the EP Nucleic Acid Test Cartridges component may experience elevated false positive results for Yersinia enterocolitica. The recall covers 790 Cartridge Carriers containing 3160 Cartridges distributed in Arizona, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Minnesota, Missouri, New Hampshire, Tennessee, Texas, Utah, West Virginia, and Wisconsin.
Context
GovInfoNow's records show Luminex Corporation has had 22 other recalls on record since June 29, 2018. Other recent recalls of similar products include the Biomerieux VITEK 2 AST-N461 Test Kit Recall (July 24, 2026), the Changchun Wancheng Bio-Electron UTI Test Strips Recall (Nov. 22, 2025), and the Biomerieux VITEK 2 AST-N447 Kit Recall (June 4, 2026).
How to tell if you have this one
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.
Brand
Luminex
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Verify the kit catalog number (20-005-023) and cartridge model (20-006-023) to confirm if your test is affected.
Where it went and when
Where it was distributed
Distributed in 17 states.
Listed by the agency
Not listed
FDA distribution: “Domestic Distribution: Arizona, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Minnesota, Missouri, New Hampshire, Tennessee, Texas, Utah, West Virginia, Wisconsin.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Minnesota, Missouri, New Hampshire, Tennessee, Texas, Utah, West Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2952-2018 (May 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2952-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.