FDA Enforcement
Class III
Ongoing
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
Recall: Z-2225-2023
·
Reported August 2, 2023
Enforcement
- Recall Number
- Z-2225-2023
- Event ID
- 92485
- Classification
- Class III
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Ortho-Clinical Diagnostics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 2, 2023
- Initiation Date
- May 18, 2023
- Classification Date
- July 21, 2023
- Address
- 100 Indigo Creek Dr, N/A, Rochester, NY, 14626-5101, United States
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
May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).
Code Info
UDI-DI: 10758750033324 Lot # 0090, Expiration Date: 19-Jun-2023
Distribution
US Nationwide distribution in the state of CA.
Quantity
2 units