Class II — Arkray Factory USA, Inc.
| Recalling firm | ARKRAY FACTORY USA, Inc. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | AUTION HYBRID AU-4050 |
| Quantity | 159 units |
| Distribution | US |
| Initiated | 2019-05-03 |
| Classified | 2019-06-20 |
| Terminated | 2020-09-17 |
| Recall number | Z-1850-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Arkray Factory USA, Inc. (Z-1850-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82737/
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