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FDAOctober 19, 2018device

VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vitro quantitative measurement of a variety of analytes of clinical interest in certain biological fluids (depending on the analyte) such as serum, plasma, urine and cerebrospinal fluid.

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

The hazard

Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.

What to do

FDA enforcement status: Terminated

Brands named

ortho clinical diagnosticsorthoortho clinical

UPCs

10758750012343

Recall history

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

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