Z-2225-2023 Class III Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 2, 2023
- Initiation Date
- May 18, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
Product Description
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
Reason for Recall
May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).
Distribution Pattern
US Nationwide distribution in the state of CA.
Code Information
UDI-DI: 10758750033324 Lot # 0090, Expiration Date: 19-Jun-2023