Company: Arkray Factory USA, Inc.
Date of Enforcement Report: 6/26/2019
Class II
PRODUCT
AUTION HYBRID AU-4050
Recall Number: Z-1850-2019
REASON
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.
RECALLING FIRM/MANUFACTURER
Arkray Factory USA, Inc. on 5/3/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
159 units
DISTRIBUTION
US Nationwide