Aution Hybrid Au-4050 recallZ-1850-2019 · Arkray Factory USA, Inc. · initiated May 3, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Arkray Factory USA, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-1850-2019
- Status
- Terminated
- Initiated by the company
- May 3, 2019
- Recalling firm
- Arkray Factory USA, Inc.
- Quantity
- 159 units
- Product code
- KQO
- FDA submissions
- K121456
- Distribution
- US
Product description
AUTION HYBRID AU-4050
Code information (models, lots, serial numbers)
UDI: (01) 00015482146030 All serial numbers
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Aution™ Hybrid AU-4050 Chemical Analyzer 14603Arkray USA, Inc. · Automated Urinalysis System1 recall4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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