Lower risk Medical device recall · FDA · Published December 10, 2018

Luminex VERIGENE Processor SP Model 10-0000-07: Incorrect Test Results Risk

Luminex recalls VERIGENE Processor SP Model 10-0000-07 due to potential incorrect test results from hybridization heater failure. Affected units may need repair or replacement.

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

🇺🇸 FDA recall #Z-0054-2021Medical device Luminex ›

Lower-risk recall

No results/incorrect results due to failure of the hybridization heater.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Luminex is recalling its VERIGENE Processor SP Model 10-0000-07 because the hybridization heater can fail, causing no results or incorrect test results. This affects lab users who rely on this device for nucleic acid testing. Read more at govinfonow.com/recall/69361-luminex-verigene-processor-sp-model-10-0000-07-incorrect-test.

Source Summary by GovInfoNow · govinfonow.com/recall/69361-luminex-verigene-processor-sp-model-10-0000-07-incorrect-test · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0054-2021

Cite this page

“Luminex VERIGENE Processor SP Model 10-0000-07: Incorrect Test Results Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69361-luminex-verigene-processor-sp-model-10-0000-07-incorrect-test. Based on FDA recall #Z-0054-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0054-2021%22&limit=1).

The FDA announced on 2018-12-10 that Luminex Corporation voluntarily recalled the VERIGENE Processor SP (Model No. 10-0000-07) due to a hazard of no or incorrect results caused by a failure of the hybridization heater.

How to tell if you have it

Brand: Luminex
Product: VERIGENE Processor SP
Model No.: 10-0000-07
Catalogue Number: 10-0000-07
Serial No.: 14230205
UDI Code: 00857573006010
Quantity: 1 system
Distribution: US distribution in MO

The hazard

The device may produce no results or incorrect results due to the failure of the hybridization heater, according to the FDA.

Context

GovInfoNow's records show Luminex Corporation has had 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 LH One Step Ovulation Test Device Recall (2025-11-22).

How to tell if you have this one

Check for the model number 10-0000-07 on the device. Affected units have Serial No. 14230205 or UDI Code 00857573006010.

Brand
Luminex
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Model
Look for the model number 10-0000-07 on the device label.
Contact Luminex
Reach out to Luminex Corporation for guidance on next steps.

Where it went and when

Where it was distributed

Distributed in Missouri.

FDA distribution: “US distribution in MO. No OUS” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Missouri.

Recall timeline

FDA published this recall 22 months after the firm started it.

Dec 10, 2018Firm started the recall
Oct 5, 2020FDA classified it Class II
Oct 14, 2020Published in FDA’s Enforcement Report

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

Similar recalls

Latest medical device recalls

Keep exploring

More Luminex recalls

Link to this recall

<a href="https://govinfonow.com/recall/69361-luminex-verigene-processor-sp-model-10-0000-07-incorrect-test">Luminex VERIGENE Processor SP Model 10-0000-07: Incorrect Test 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-0054-2021 (December 10, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0054-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.