Device product
VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
Z-1109-2022
Product summary
- Event
- Event 90129
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 984 units
- Official record key
device-enforcement:Z-1109-2022
Official wording
Reason: Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.
Code information: Lot Number 101321021B
Distribution pattern: US
Derived failure modes
-
Unknown
Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.