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FDAApril 26, 2017device

enGen Track System with TCAutomation Software Version 4.2

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

The hazard

A software anomaly with TCA Software V4.2 may potentially cause a delay in reporting of results due to patient samples being routed to an unintended location when samples are reintroduced back onto the enGEN track

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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