FDASeptember 22, 2017device

VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic

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

The hazard

This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control.

What to do

FDA enforcement status: Terminated

Brands named

ortho clinical diagnosticsorthoortho clinical

Recall history

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

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