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FDANovember 20, 2020device

VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical and post-analytical sample processing in the clinical laboratory.

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

The hazard

A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may lead to results being associated with the wrong patient sample and potentially lead to inappropriate intervention with the potential for injury to the patient.

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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VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product Usage: intended to automate pre-analytical and post-analytical sample processing in the clinical laboratory. — Recall Details · AllClear