FDAMay 3, 2019device

AUTION HYBRID AU-4050

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

The hazard

This correction is being initiated due to a software issue which results in the possibility of incorrect patient information being assigned to sample results when the following rare combination of three specific events were to occur: 1) No measurement results are generated due to an error by a urine sediment measurement. 2) The instrument is shutdown incorrectly. 3) An item rack is used for subsequent sample measurements.

What to do

FDA enforcement status: Terminated

Brands named

arkray factoryarkray

UPCs

00015482146030

Recall history

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

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