Ortho-Clinical Diagnostics, Inc.: Medical Device Recall in 2023 - (Recall #: Z-2225-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

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

Product Classification:

Class III

Date Initiated: May 18, 2023

Date Posted: August 2, 2023

Recall Number: Z-2225-2023

Event ID: 92485

Reason for Recall:

May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).

Status: Ongoing

Product Quantity: 2 units

Code Information:

UDI-DI: 10758750033324 Lot # 0090, Expiration Date: 19-Jun-2023

Distribution Pattern:

US Nationwide distribution in the state of CA.

Voluntary or Mandated:

Voluntary: Firm initiated