Lower riskMedical device recall · FDA · Published August 3, 2021
Luminex Verigene EP Amplification Reagent Kit Test Recall: False Positive Risk
Luminex recalls Verigene EP Amplification Reagent Kit Test with potential for false positive results. Affected lots include specific model numbers and dates. Consumers should check their kit's lot number and contact Luminex for details.
“Luminex Verigene EP Amplification Reagent Kit Test Recall: False Positive Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62090-luminex-verigene-ep-amplification-reagent-kit-test-recall-false-positive. Based on FDA recall #Z-2451-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2451-2021%22&limit=1).
The FDA announced on August 3, 2021, that Luminex Corporation is recalling the Verigene EP Amplification Reagent Kit Test due to the potential for false positive results. Owners should contact the company for a remedy.
According to the FDA, there is potential for false positive results from the recalled kits.
Context
GovInfoNow's records show Luminex Corporation has 22 other recalls on record since 2018-05-08. Other recent recalls of similar products include Luminex VERIGENE Gram Negative Blood Culture Test Recall (2025-04-16), Luminex Verigene Gram Positive Blood Culture Test Recall (2024-06-20), and Luminex VERIGENE BC-GP Utility Tray Recall (2023-11-07). Other recent recalls of similar products include Biomerieux VITEK 2 AST-N461 Test Kit Recall (2026-07-24), Biomerieux VITEK 2 AST-N447 Kit Recall (2026-06-04), and Changchun Wancheng Bio-Electron UTI Test Strips Recall (2025-11-22).
How to tell if you have this one
Check the lot number on the Verigene EP Amplification Reagent Kit Test packaging. Affected lots include specific numbers like 111620023A, 010421023A, and others listed in the recall notice.
Brand
Luminex
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Lot Number
Look for the lot number on the Verigene EP Amplification Reagent Kit Test packaging to determine if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution and the countries of Austria, France, Greece, Japan, and Turkey.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 50 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-2451-2021 (August 3, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2451-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.