Arkray Factory USA, Inc. recalls AUTION HYBRID AU-4050

Recall date

May 3, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1850-2019

FDA classification

Class II

Brand / firm

Arkray Factory USA, Inc.

Sold / distributed

US

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

AUTION HYBRID AU-4050