Luminex VERIGENE Enteric Pathogens Test May Give False Negatives Due to Swab
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.
Lower-risk recall
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.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/60480-luminex-verigene-enteric-pathogens-test-may-give-false-negatives-due.
Source Summary by GovInfoNow · govinfonow.com/recall/60480-luminex-verigene-enteric-pathogens-test-may-give-false-negatives-due · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1335-2022
Cite this page
“Luminex VERIGENE Enteric Pathogens Test May Give False Negatives Due to Swab.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60480-luminex-verigene-enteric-pathogens-test-may-give-false-negatives-due. Based on FDA recall #Z-1335-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1335-2022%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Luminex- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide distribution - US Nationwide and the countries of Kuwait, Austria, France, Greece, Kuwait, Turkey.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1334-2022 | Verigene CDF Nucleic Acid Test, Part No. 30-002-22; UDI 00840487101735 Luminex Lot Number 042021022D, FLOQ Swab Lot Numbers: 2100856, 2032870; Luminex Lot Number 071321022F, FLOQ Swab Lot Numbers: 2100856, 2107946; Luminex Lot Number 100421022A, FLOQ Swab Lot Numbers: 2110850; Luminex Lot Number 110221022E, FLOQ Swab Lot Numbers: 2107946. | 296 units |
| Z-1335-2022 | VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23; UDI 00840487101568 Luminex Lot Number 030121023A, FLOQSwab Lot Number: 2100856; Luminex Lot Number 030221023D, FLOQSwab Lot Number: 2100856; Luminex Lot Number 030221023E, FLOQSwab Lot Number: 2100856; Luminex Lot Number 030221023F, FLOQSwab Lot Number: 2100856; Luminex Lot Number 030821023A, FLOQSwab Lot Number: 2100856; Luminex Lot Number 030921023D, FLOQSwab Lot Number: 2100856; Luminex Lot Number 031021023E, FLOQSwab Lot Number: 2100856; Luminex Lot Number 031621023D, FLOQSwab Lot Number: 2100856; Luminex Lot Number 031721023D, FLOQSwab Lot Number: 2100856; Luminex Lot Number 032221023A, FLOQSwab Lot Number: 2032870; Luminex Lot Number 032421023E, FLOQSwab Lot Number: 2032870; Luminex Lot Number 032521023E, FLOQSwab Lot Number: 2100856; Luminex Lot Number 033021023E, FLOQSwab Lot Number: 2100856; Luminex Lot Number 041421023F, FLOQSwab Lot Number: 2100856; Luminex Lot Number 050521023H, FLOQSwab Lot Number: 2100856; Luminex Lot Number 050621023C, FLOQSwab Lot Number: 2032870; Luminex Lot Number 051221023E, FLOQSwab Lot Number: 2100856; Luminex Lot Number 051221023F, FLOQSwab Lot Number: 2100856, 2032870; Luminex Lot Number 051721023B, FLOQSwab Lot Number: 2100856, 2032870; Luminex Lot Number 052721023D, FLOQSwab Lot Number: 2107946; Luminex Lot Number 060121023A, FLOQSwab Lot Number: 2107946; Luminex Lot Number 060921023C, FLOQSwab Lot Number: 2032870; Luminex Lot Number 062321023E, FLOQSwab Lot Number: 2107946; Luminex Lot Number 062921023D, FLOQSwab Lot Number: 2107946; Luminex Lot Number 063021023D, FLOQSwab Lot Number: 2110850; Luminex Lot Number 063021023E, FLOQSwab Lot Number: 2107946; Luminex Lot Number 070121023D, FLOQSwab Lot Number: 2107946; Luminex Lot Number 070621023A, FLOQSwab Lot Number: 2107946; Luminex Lot Number 070821023G, FLOQSwab Lot Number: 2107946; Luminex Lot Number 070821023H, FLOQSwab Lot Number: 2107946; Luminex Lot Number 080321023C, FLOQSwab Lot Number: 2107946; Luminex Lot Number 081621023D, FLOQSwab Lot Number: 2110850; Luminex Lot Number 081721023F, FLOQSwab Lot Number: 2107946, 2110850; Luminex Lot Number 081721023G, FLOQSwab Lot Number: 2110850; Luminex Lot Number 081921023D, FLOQSwab Lot Number: 2110850; Luminex Lot Number 082021023D, FLOQSwab Lot Number: 2100856; Luminex Lot Number 082021023E, FLOQSwab Lot Number: 2110850; Luminex Lot Number 082521023D, FLOQSwab Lot Number: 2100856, 2110850; Luminex Lot Number 082621023D, FLOQSwab Lot Number: 2110850; Luminex Lot Number 083121023D, FLOQSwab Lot Number: 2110850; Luminex Lot Number 090821023D, FLOQSwab Lot Number: 2100856; Luminex Lot Number 091521023D, FLOQSwab Lot Number: 2032870; Luminex Lot Number 091621023D, FLOQSwab Lot Number: 2100856; Luminex Lot Number 091621023G, FLOQSwab Lot Number: 2110850; Luminex Lot Number 092721023A, FLOQSwab Lot Number: 2110850; Luminex Lot Number 092821023E, FLOQSwab Lot Number: 2110850; Luminex Lot Number 092921023E, FLOQSwab Lot Number: 2110850; Luminex Lot Number 100621023C, FLOQSwab Lot Number: 2110850; Luminex Lot Number 101221023D, FLOQSwab Lot Number: 2110850; Luminex Lot Number 101321023D, FLOQSwab Lot Number: 2110850; Luminex Lot Number 101921023G, FLOQSwab Lot Number: 2110850; Luminex Lot Number 102021023E, FLOQSwab Lot Number: 2107946, 2110850; Luminex Lot Number 102221023D, FLOQSwab Lot Number: 2110850; Luminex Lot Number 102821023F, FLOQSwab Lot Number: 2107946. | 5601 units |
What to do — step by step
Check Your Kit Lot Numbers
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.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Kuwait, Austria, France, Greece, Kuwait, 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 26 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-1335-2022 (June 17, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1335-2022 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.