VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray — Class II medical device recall Z-1109-2022
Ongoing recall by Luminex Corporation, reported 2022-05-25. Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the e
| Recall number | Z-1109-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Luminex Corporation, Northbrook, IL, United States |
| Recall initiated | 2022-02-15 |
| Classified | 2022-05-17 |
| Reported by FDA | 2022-05-25 |
| Quantity | 984 units |
| Lot numbers | 101321021B |
| Model numbers | 20-009-021 |
Product
VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
Reason for recall
Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1109-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.