Device product
DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis
Z-1597-2023
Product summary
- Event
- Event 92056
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 107 units
- Official record key
device-enforcement:Z-1597-2023
Official wording
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.
Code information: UDI/DI 15099590748647, All analyzers with Windows 10, Software Versions 8.5, 8.5.1 and 8.6
Distribution pattern: Worldwide Distribution
Derived failure modes
-
Unknown
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.