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U.S. Department of Health and Human Services

Class 2 Device Recall AUTION HYBRID AU4050

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  Class 2 Device Recall AUTION HYBRID AU4050 see related information
Date Initiated by Firm May 03, 2019
Create Date June 20, 2019
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = ARKRAY, INC.
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