FDA recall Z-2225-2023

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 for recall

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

Distribution

US Nationwide distribution in the state of CA.

Key facts

Status

Ongoing

Initiation date

2023-05-18

Report date

2023-08-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rochester, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2225-2023