Device product
VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
Z-0054-2021
Product summary
- Event
- Event 86358
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 system
- Official record key
device-enforcement:Z-0054-2021
Official wording
Reason: No results/incorrect results due to failure of the hybridization heater.
Code information: Catalogue Number: 10-0000-07 Serial No. 14230205 UDI Code: 00857573006010
Distribution pattern: US distribution in MO. No OUS
Derived failure modes
-
Unknown
No results/incorrect results due to failure of the hybridization heater.