Device product
UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer
Z-0236-2018
Product summary
- Event
- Event 78611
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 units
- Official record key
device-enforcement:Z-0236-2018
Official wording
Reason: The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.
Code information: Serial Numbers: B24802: AW10161, AW10154, AZ34449, AZ34447 629029: AT40563, AT06096, AT06095, AT02044, AW05080, AW05072, AW05066, AT50679, AS49422, AS36312, AS23151
Distribution pattern: CA, AR, HI, CA, OH, WA, MD, Canada, Japan
Derived failure modes
-
Unknown
The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.