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FDAApril 6, 2016device

VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifier No. 10758750002740; and VITROS 5600 Integrated System (refurbished), Catalog Number 6802915, Unique Device Identifier No. 10758750007110; IVD.

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

The hazard

Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense into an unintended sample that may lead to erroneous or contaminated results.

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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