Z-1850-2019Class II

Aution Hybrid Au-4050

Name: Z-1850-2019 Aution Hybrid Au-4050
Creator: Arkray Factory USA, Inc.
Published: 2019-05-03
License: https://open.fda.gov/license/

Arkray Factory USA, Inc. / initiated 2019-05-03 / Terminated / root cause: software

FDA source

Arkray Factory USA, Inc. began a recall of AUTION HYBRID AU-4050 on 2019-05-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1850-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-03
Posted: 2019-06-20
Terminated: 2020-09-17
Recalling firm: Arkray Factory USA, Inc.
Product: Aution Hybrid Au-4050
Product code: KQO Automated Urinalysis System
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.
Root cause tag: software
FDA root 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
Product codes and lots: UDI: (01) 00015482146030 All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1850-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1850-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-26	2019-06-20

Product code KQO

K121456Class IAution Hybrid Au-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9Ha Urine Test Strips; Aution ControlArkray, Inc. / cleared 2013-02-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)