Drug recall
VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
FDA recall event 90129 · Class II · Luminex Corporation
Key facts
| Event ID | 90129 |
|---|---|
| Recall numbers | Z-1109-2022 |
| Recalling firm | Luminex Corporation |
| Product type | Devices |
| Products | VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Feb 15, 2022 |
| Report date | May 25, 2022 |
| City | Northbrook |
| State | IL |
| Country | United States |
| FEI number | 3006028115 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: