Device product
VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP). Catalog Number: 6192257, Lot number: 0090
Z-2225-2023
Product summary
- Event
- Event 92485
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 2 units
- Official record key
device-enforcement:Z-2225-2023
Official wording
Reason: May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).
Code information: UDI-DI: 10758750033324 Lot # 0090, Expiration Date: 19-Jun-2023
Distribution pattern: US Nationwide distribution in the state of CA.
Derived failure modes
-
Potency or specification failure
May not meet the stability specifications