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FDAOctober 16, 2020device

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:...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

ortho clinical diagnosticsorthoortho clinical

UPCs

10758750004577

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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