Lower riskMedical device recall · FDA · Published April 22, 2019
Luminex Verigene Processor SP Recall: No Call Results Issue
Luminex recalls Verigene Processor SP models 10-0000-07 and 10-0000-07-R due to repeated No Call results. Affected units have specific serial numbers listed in the recall notice.
Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.
Take action
Contact the company
📍Recalling firmLuminex Corporation4088 Commercial Ave · Northbrook, IL 60062-1829
✎ GovInfoNow plain-language explainer
Luminex is recalling Verigene Processor SP devices with model numbers 10-0000-07 and 10-0000-07-R because customers report getting no results from these devices. This issue could affect lab testing accuracy and requires attention to ensure proper results. Read more at govinfonow.com/recall/68107-luminex-verigene-processor-sp-recall-no-call-results-issue.
“Luminex Verigene Processor SP Recall: No Call Results Issue.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68107-luminex-verigene-processor-sp-recall-no-call-results-issue. Based on FDA recall #Z-0920-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0920-2022%22&limit=1).
Luminex Corporation voluntarily recalled Verigene Processor SP units on April 22, 2019, after customers reported repeatedly obtaining No Call results, according to the FDA. The Food and Drug Administration announced the Class II recall of four units distributed in Texas, Connecticut, and Louisiana.
How to tell if you have it
Brand: Luminex
Product: Verigene Processor SP
Model Numbers: 10-0000-07, 10-0000-07-R
Serial Numbers (Model 10-0000-07): 13042054, 16347082, 17215010
Serial Numbers (Model 10-0000-07-R): 18079010
Quantity: 4 units
Distribution: Texas, Connecticut, Louisiana
The hazard
Two of three complaints were initiated due to customers repeatedly obtaining No Call results on the Processor SPs in question. The FDA classified this as a Class II recall.
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).
How to tell if you have this one
Check for model numbers 10-0000-07 or 10-0000-07-R on the device. Affected units have specific serial numbers listed in the recall notice: 13042054, 16347082, 17215010 for model 10-0000-07 and 18079010 for model 10-0000-07-R.
Brand
Luminex
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Model
Verify the model number on your Verigene Processor SP device to see if it matches 10-0000-07 or 10-0000-07-R.
Contact Luminex
Reach out to Luminex Corporation for guidance on next steps if your device is affected.
Where it went and when
Where it was distributed
Distributed in 3 states.
Listed by the agency
Not listed
FDA distribution: “US: TX, CT, LA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Connecticut, Louisiana, Texas.
Recall timeline
FDA published this recall 3 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0920-2022 (April 22, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0920-2022 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.