Luminex VERIGENE Processor SP Recall: False-negative results for foodborne pathogens
Luminex Corporation recalls VERIGENE Processor SP devices with specific serial numbers due to potential false-negative results for Vibrio parahaemolyticus, Salmonella, and Shigella. Affected units may not detect these pathogens correctly when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit.
Lower-risk recall
Potential for a false-negative result for Vibrio parahaemolyticus, Salmonella, and/or Shigella spp when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit.
Contact the company
What happened, in plain English
Luminex Corporation is recalling VERIGENE Processor SP devices with specific serial numbers because they can produce false-negative results for Vibrio parahaemolyticus, Salmonella, and Shigella when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit. This means the device might fail to detect these harmful bacteria, potentially leading to missed infections. Read more at govinfonow.com/recall/63041-luminex-verigene-processor-sp-recall-false-negative-results-for-foodborne.
Source Summary by GovInfoNow · govinfonow.com/recall/63041-luminex-verigene-processor-sp-recall-false-negative-results-for-foodborne · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1488-2021
Cite this page
“Luminex VERIGENE Processor SP Recall: False-negative results for foodborne pathogens.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63041-luminex-verigene-processor-sp-recall-false-negative-results-for-foodborne. Based on FDA recall #Z-1488-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1488-2021%22&limit=1).
Why it’s dangerous
The VERIGENE Processor SP device can produce false-negative results for Vibrio parahaemolyticus, Salmonella, and Shigella when used with the VERIGENE Enteric Pathogens Nucleic Acid Test Kit. This means the device might fail to detect these harmful bacteria, potentially leading to missed infections and incorrect health assessments.
Who’s affected
Users of the VERIGENE Processor SP device with specific serial numbers listed in the recall are affected. Laboratory personnel and healthcare providers who use this device for pathogen testing are most at risk of missing infections due to false-negative results.
How to tell if you have this one
Check the serial number on your VERIGENE Processor SP device. Affected units have specific serial numbers listed in the recall, including a range of numbers starting with 13003009 through 19095014 and other serial numbers provided in the recall notice.
- Brand
Luminex- Category
Medical device
What to do — step by step
Check Serial Number
Look for the serial number on your VERIGENE Processor SP device to determine if it is affected by this recall.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - United States (nationwide) and the countries of Austria, France, Greece, Japan, Netherlands, 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 48 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-1488-2021 (March 18, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1488-2021 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.