Lower risk Medical device recall · FDA · Published April 5, 2022

Luminex Verigene Processor SP Recall: False Negative Results Risk

Luminex recalls Verigene Processor SP models 10-0000-07/10-0000-07R due to potential false negative results from temperature issues in the Verigene system.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1092-2022Medical device Luminex ›

Lower-risk recall

Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.

Take action

Contact the company

Recalling firmLuminex Corporation12212 Technology Blvd · Austin, TX 78727-6101

✎ GovInfoNow plain-language explainer

Luminex is recalling specific models of the Verigene Processor SP because the heater might not stay within proper temperature limits, which could cause false negative results in tests. This means the device might give incorrect test results if used without the recall fix. Read more at govinfonow.com/recall/60839-luminex-verigene-processor-sp-recall-false-negative-results-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/60839-luminex-verigene-processor-sp-recall-false-negative-results-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1092-2022

Cite this page

“Luminex Verigene Processor SP Recall: False Negative Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60839-luminex-verigene-processor-sp-recall-false-negative-results-risk. Based on FDA recall #Z-1092-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1092-2022%22&limit=1).

The FDA announced on April 5, 2022, that Luminex Corporation is recalling Verigene Processor SP units because a heater may operate outside temperature limits, potentially causing false negative results. Owners should contact the company for remedy details.

How to tell if you have it

Brand: Luminex
Product: Verigene Processor SP
Models: 10-0000-07/10-0000-07R
Serial Numbers (10-0000-07): 17340003, 19044007, 20133004, 18128002, 18214004, 12061048, 18191010, 13193254, 13051068, 21029902, 16277059, 19233005, 11250096, 14069051, 18255003, *18039010, *20212006, *19317004, *19206009, *18057008
Serial Numbers added 6.23.22 for 10-0000-07R: 18191010, 13051068, 14069051, *12198198, *12278344, *14322267, *12271338
Serial Numbers added 7.14.22 for 10-0000-07R: 18226007, 16242043
Serial Numbers added 7.14.22 for 10-0000-07: 17062030, 18235008, 19192006

The hazard

The heater within the Verigene System may be outside of established temperature limits for assays. This malfunction could result in false negative results.

Context

GovInfoNow's records show Luminex Corporation has 22 other recalls on record since May 8, 2018. Other recent recalls of similar products include the Luminex VERIGENE Gram Negative Blood Culture Test Recall (April 16, 2025), the Luminex Verigene Gram Positive Blood Culture Test Recall (June 20, 2024), and the Luminex VERIGENE BC-GP Utility Tray Recall (Nov. 7, 2023). Other recent recalls of similar products include the Fujirebio Lumipulse pTau 217 Plasma Controls Recall (Dec. 11, 2025), the Biomerieux VITEK 2 AST-N461 Test Kit Recall (July 24, 2026), and the Siemens Healthineers Immulite 2000 Syphilis Screen Recall (July 13, 2026).

How to tell if you have this one

Check for the model numbers 10-0000-07 or 10-0000-07R on the device. The serial numbers listed in the recall notice are specific to the affected units.

Brand
Luminex
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Model
Identify the model number on the device to see if it matches 10-0000-07 or 10-0000-07R.
Contact Luminex
Reach out to Luminex Corporation for assistance with the recall process or to confirm if your device is affected.

Where it went and when

Where it was distributed

Distributed in 16 states.

FDA distribution: “US:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT OUS: None” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Maine, Michigan, Nebraska, Ohio, Pennsylvania, Texas, Vermont, Washington.

Recall timeline

FDA published this recall 50 days after the firm started it.

Apr 5, 2022Firm started the recall
May 13, 2022FDA classified it Class II
May 25, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/60839-luminex-verigene-processor-sp-recall-false-negative-results-risk">Luminex Verigene Processor SP Recall: False Negative Results Risk (GovInfoNow)</a>

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-1092-2022 (April 5, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1092-2022 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.