Luminex VERIGENE Nucleic Acid Test Kit Extraction Tray Recall: No Call Control Failures
Luminex recalls specific VERIGENE Nucleic Acid Test Kit extraction trays due to potential no call internal control failures from missing reagents. Affected units include lot 101321021B.
Lower-risk recall
Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.
Contact the company
What happened, in plain English
Luminex is recalling a specific extraction tray for nucleic acid tests because a small subset of units may have missing reagents, causing no call internal control failures. This could lead to inaccurate test results if the tray is used without proper reagent levels. Read more at govinfonow.com/recall/61140-luminex-verigene-nucleic-acid-test-kit-extraction-tray-recall-no.
Source Summary by GovInfoNow · govinfonow.com/recall/61140-luminex-verigene-nucleic-acid-test-kit-extraction-tray-recall-no · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1109-2022
Cite this page
“Luminex VERIGENE Nucleic Acid Test Kit Extraction Tray Recall: No Call Control Failures.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61140-luminex-verigene-nucleic-acid-test-kit-extraction-tray-recall-no. Based on FDA recall #Z-1109-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1109-2022%22&limit=1).
Why it’s dangerous
The extraction tray may have missing reagents in a small subset of units, leading to no call internal control failures. This means the test results could be inaccurate if the tray is used without the proper reagent levels.
Who’s affected
Users of the VERIGENE Nucle:ic Acid Test Kit-BC-GN Extraction Tray with lot number 101321021B are affected. Laboratory personnel and healthcare providers using this specific tray model are most at risk.
How to tell if you have this one
Check for the lot number 101321021B on the VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray (9.73 mL, REF 20-009-021).
- Brand
Luminex- Category
Medical device
What to do — step by step
Check for Lot Number
Look for the lot number 101321021B on the extraction tray packaging or label.
How this recall unfolded
Recall timeline
FDA published this recall 3 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-1109-2022 (February 15, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1109-2022 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.