Device product
iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700-3375; in-vitro diagnostic device, urine analysis, c) iQ200 Select 1500, Part Number 700-3347, d) iQ200 Sprint, Part Number 700-3325
Z-1596-2023
Product summary
- Event
- Event 92056
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1068 units
- Official record key
device-enforcement:Z-1596-2023
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: a) iQ 200 Select, Part Numbers C10684, UDI/DI 15099590695484 and 700-3345, UD/DI 10837461001300; b) iQ 200 Elite, Part Numbers C10683, UDI/DI 15099590697129 and 700-3375, UDI/DI 10837461001355; c) iQ200 Select 1500, Part Number 700-3347, UD/DI 10837461001317; d) iQ200 Sprint, Part Number 700-3325, UDI/DI 10837461001256; All analyzers with Windows 10, Software Version 8.1;
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.