FDA Medical Device Recalls (openFDA)
Arkray Factory USA, Inc.: AUTION HYBRID AU-4050
- Recall number
- Z-1850-2019
- Recalling firm
- Arkray Factory USA, Inc.
- Product
- AUTION HYBRID AU-4050
- Status
- Terminated
- Initiated
- 2019-05-03
- Posted
- not on file
- Terminated
- 2020-09-17
- 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.
- 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
- 159 units
- Distribution
- US
- Lot, serial or model codes
- UDI: (01) 00015482146030 All serial numbers
- 510(k) numbers
- ["K121456"]
- PMA numbers
- not on file
- Product code
- KQO
- Firm FEI
- 1832816
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28