Beckman Coulter, Inc. Recall 92056
Description: DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
Beckman Coulter, Inc. Recall 92056 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1598-2023 |
| Event ID | 92056 |
| Event Description | DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis |
| Product Type | Devices |
| Distribution | Worldwide Distribution |
| Quantity | 355 units |
| Recall Reason | Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have been investigated. |
| Device Classification | 20230524 |
| Device Code Info | UDI/DI 15099590748654, All analyzers with Windows 10, Software Versions 8.5, 8.5.1 and 8.6 |
| Center Classification Date | 20230517 |
| Recall Initiation Date | 20230405 |
| Recalling Firm | Beckman Coulter, Inc. |
| Initial Notification | Letter |
| Similar To |