FDA-Device2019-06-26Class II
AUTION HYBRID AU-4050
Arkray Factory USA, Inc.
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.
Sold states
US
Affected count
159 units
Manufactured in
5182 W 76th St, N/A, Minneapolis, MN, United States
Products
AUTION HYBRID AU-4050
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1850-2019Don't want to check this manually?
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