medical Class III Updated 2020-11-25

Ortho Clinical Diagnostics Inc recalls VITROS Chemistry Products Performance Verifier II-For in vit

Recalled Product

VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated System - Product Code: 8231474

Hazard / Issue

Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Q7692 , EXP: 01-NOV-2021 UDI: 10758750004577
View official government recall

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