Drug recall
AUTION HYBRID AU-4050
FDA recall event 82737 · Class II · Arkray Factory USA, Inc.
Key facts
| Event ID | 82737 |
|---|---|
| Recall numbers | Z-1850-2019 |
| Recalling firm | Arkray Factory USA, Inc. |
| Product type | Devices |
| Products | AUTION HYBRID AU-4050 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | May 3, 2019 |
| Report date | Jun 26, 2019 |
| Termination date | Sep 17, 2020 |
| City | Minneapolis |
| State | MN |
| Country | United States |
| FEI number | 1832816 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: