FDAMarch 10, 2015device

Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, Global Trade Item Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Global Trade Item Number 10758750001644; IVD. Intended for use in the in vitro quantitative, se...

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

The hazard

Software Anomaly; It is possible for the device to process samples with a cartridge other than the intended cartridge, potentially leading to erroneous patient results. If this anomaly occurred previously, an indication would be a series of results that were similar across multiple samples (i.e., results could be believable or outside of the Reportable Range for the intended assay).

What to do

FDA enforcement status: Terminated

Brands named

ortho clinical diagnosticsorthoortho clinical

UPCs

1075875000113210758750001644

Recall history

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

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