Recall – Urine analyzer software error can lead to incorrect patient data

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

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.