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Arkray Factory USA, Inc. recalls AUTION HYBRID AU-4050
Recalled June 26, 2019 · FDA recall Z-1850-2019 · Arkray Factory USA
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. · FDA Class II
Units
159 units
Sold at
US
Description
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.
Product
AUTION HYBRID AU-4050
Manufacturer(s)
Arkray Factory USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →