Home / Recalls / Medical Devices
Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the
Recalled August 2, 2023 · FDA recall Z-2225-2023 · Ortho-Clinical Diagnostics
Hazard
May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU). · FDA Class III
Units
2 units
Sold at
US Nationwide distribution in the state of CA.
Description
May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).
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
Manufacturer(s)
Ortho-Clinical Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →