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

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
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QSS Software Validation
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Location: Boston, MA, USA
Dates:  June 2-4, 2020
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