Luminex Verigene RP Flex Test May Give False Negatives
Luminex recalls Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model 20-006-024 due to potential false-negative results. Consumers should check product codes for affected units.
Lower-risk recall
Potential for a false-negative result.
Contact the company
What happened, in plain English
Luminex is recalling a specific model of respiratory pathogen test kit because it may give false-negative results. This means the test might incorrectly show a negative result when the person is actually infected, potentially leading to missed diagnoses. Read more at govinfonow.com/recall/64023-luminex-verigene-rp-flex-test-may-give-false-negatives.
Source Summary by GovInfoNow · govinfonow.com/recall/64023-luminex-verigene-rp-flex-test-may-give-false-negatives · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2006-2021
Cite this page
“Luminex Verigene RP Flex Test May Give False Negatives.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64023-luminex-verigene-rp-flex-test-may-give-false-negatives. Based on FDA recall #Z-2006-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2006-2021%22&limit=1).
Why it’s dangerous
The test may produce a false-negative result, meaning it could show that a person does not have a respiratory infection when they actually do. This could lead to a missed diagnosis and potential spread of infection if the person is not treated.
Who’s affected
People who purchased the Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) model 20-006-024 with the listed serial numbers are affected. Those using the test for respiratory infections are most at risk of missing a diagnosis.
How to tell if you have this one
Check the product's model number and serial code on the packaging or label. Affected units have the model number 20-006-024 and specific serial codes listed in the recall notice.
- Brand
Luminex- Category
Medical device
All 6 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 including in the states of AL, AZ, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA and VT. The countries of Austria, Chile, France, Germany, Greece, Italy, Japan, Kuwait, Netherlands, Spain, Thailand, Turkey, and United Kingdom.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2006-2021 | Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024; 030520024A, 030720024A, 031020024A, 031120024A, 031320024A, 031620024C, 031820024A, 031920024A, 032120024A, 032320024A, 032420024A, 032620024A, 033120024A, 040220024A, 040320024A, 040420024A, 040620024A, 040720024A, 040920024A, 041120024A, 041420024A, 041620024A, 041820024A, 042020024A, 042120024A, 042320024A, 042520024A, 060320024A, 061320024A, 062320024A, 070820024A, 071020024A, 072120024A, 072920024A, 080720024A, 081920024A and 091120024A | 38,990 |
| Z-2007-2021 | Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018; 030620018A, 031420018A, 032020018A, 040120018A, 041020018B, 041720018B, 042420018A, 043020018A, 050220018A, 050720018A, 050920018A, 051320018A, 051420018A, 051520018A, 052020018A,052120018A, 052920018A, 060220018A, 060920018A, 061020018A, 061620018A, 061920018D, 062020018A, 062620018A, 063020018A, 070720018A, 071620018A, 072320018A, 073020018A, 080520018A, 082020018A, 082520018A, 082820018A, and 090120018A | 36,416 |
| Z-2008-2021 | Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021; 030320021B, 031220021A, 032720021B, 040820021A, 041020021A, 041720021A, 042220021A, 042920021A, 050520021A, 051220021A, 051920021A, 053020021A, 060520021A, 061220021A, 061720021A, 070120021A, 072420021A, 081820021B, and 082620021A | 17,110 |
| Z-2009-2021 | Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023; 030420023A, 031720023A, 032520023A, 040820023B, 041520023B, 042220023B, 042820023A, 050120023A, 050620023B, 050820023B, 052720023A, 052820023A, 060420023A, 060620023A, 061120023A, 061820023A, 062520023A, 062720023A, 070220023A, 070920023A, 071420023A, 071720023A, 072820023A, 080420023A, and 090920023A | 24,338 |
| Z-2010-2021 | Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022; 041520022A, 061920022A, and 081120022A | 1,261 |
| Z-2011-2021 | Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026; 050620026A and 072120026B, | 165 |
What to do — step by step
Check Product Details
Look for the model number 20-006-024 and the listed serial codes on the test kit packaging or label.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 40 states.
FDA distribution: “Worldwide distribution - US Nationwide including in the states of AL, AZ, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA and VT. The…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia.
Recall timeline
FDA published this recall 8 months 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-2006-2021 (October 30, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2006-2021 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.