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FDAApril 6, 2015device

VITROS 5600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use.

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

The hazard

Software anomaly allows testing of multiple assays using a single urine specimen, regardless of the pretreatment requirements for each selected assay, potentially leading to biased patient results.

What to do

FDA enforcement status: Terminated

Brands named

ortho clinical diagnosticsorthoortho clinical

UPCs

10758750002740

Recall history

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

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VITROS 5600 Chemistry System, Software Version 3.2 & Below. Automates pre-analytical and post-analytical sample and data management for in vitro diagnostic use. — Recall Details · AllClear