FDA Device recall Z-1598-2023
DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
- FDA Device
- Class II
- ongoing
- Published 2023-05-24
On 2023-05-24 the FDA classified a Class II recall of DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis by Beckman Coulter, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1598-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-04-05 |
| Published | 2023-05-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Beckman Coulter |
| Distribution | n/a |
Product
DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
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.
Identifiers
| code_info | UDI/DI 15099590748654, All analyzers with Windows 10, Software Versions 8.5, 8.5.1 and 8.6 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1598-2023%22
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