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

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just 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, TX) and Canada.