AUTION HYBRID AU-4050 — Class II medical device recall Z-1850-2019
Terminated recall by Arkray Factory USA, Inc., reported 2019-06-26. This correction is being initiated due to a software issue which results in the possibility of incorrect patie
| Recall number | Z-1850-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arkray Factory USA, Inc., Minneapolis, MN, United States |
| Recall initiated | 2019-05-03 |
| Classified | 2019-06-20 |
| Reported by FDA | 2019-06-26 |
| Terminated | 2020-09-17 |
| Quantity | 159 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00015482146030 |
Product
AUTION HYBRID AU-4050
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1850-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.