Luminex Corporation Recall 90129
Description: VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
Luminex Corporation Recall 90129 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1109-2022 |
| Event ID | 90129 |
| Event Description | VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021 |
| Product Type | Devices |
| Distribution | US |
| Quantity | 984 units |
| Recall Reason | Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot. |
| Device Classification | 20220525 |
| Device Code Info | Lot Number 101321021B |
| Center Classification Date | 20220517 |
| Recall Initiation Date | 20220215 |
| Recalling Firm | Luminex Corporation |
| Initial Notification | |
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