Class 2 Device Recall AUTION HYBRID AU4050

• Date Initiated by Firm: May 03, 2019
• Create Date: June 20, 2019
• Recall Status: Terminated on September 17, 2020
• Recall Number: Z-1850-2019
• Recall Event ID: 82737
• 510(K)Number: K121456
• Product Classification: Automated urinalysis system - Product Code KQO
• Product: AUTION HYBRID AU-4050
• Code Information: UDI: (01) 00015482146030 All serial numbers
• Recalling Firm/ Manufacturer: Arkray Factory USA, Inc.; 5182 W 76th St; Minneapolis MN 55439-2900
• For Additional Information Contact: 612-835-3446
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Software design
• Action: The firm initiated the field correction by email on 05/03/2019. The letter stated how to recognize a product failure and the actions to be taking by the customer until the software upgrade is ready for installation.
• Quantity in Commerce: 159 units
• Distribution: US
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KQO