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FDAFebruary 16, 2016device

VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110. Intended for use in the in vitro measurement of a variety of analytes of clinical interest.

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

The hazard

The two sets of wires (4 total wires) exiting from the EMI filters were switched, creating a situation where a module that is intended to be de-energized will remain energized only if the associated AC power cord is unplugged.

What to do

FDA enforcement status: Terminated

Brands named

ortho clinical diagnosticsorthoortho clinical

UPCs

1075875000274010758750007110

Recall history

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

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