FDA Device recall Z-1850-2019
AUTION HYBRID AU-4050
- FDA Device
- Class II
- terminated
- Published 2019-06-26
On 2019-06-26 the FDA classified a Class II recall of AUTION HYBRID AU-4050 by Arkray Factory Usa, citing 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 ra….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1850-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-05-03 |
| Published | 2019-06-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Arkray Factory Usa |
| Distribution | n/a |
Product
AUTION HYBRID AU-4050
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.
Identifiers
| code_info | UDI: (01) 00015482146030 All serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1850-2019%22
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