Recall Z-2225-2023— Ortho-Clinical Diagnostics, Inc.
Class III · Ongoing
Class III FDA medical device recall by Ortho-Clinical Diagnostics, Inc., initiated 2023-05-18. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU)..
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2023-05-18
- Firm location
- Rochester, NY, United States
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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.