Device product
UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is the same instrument as the DxH 800 except that it is a bench top unit with no instrument cart, computer stand, and no connectivity capabilities)
Z-0237-2018
Product summary
- Event
- Event 78611
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-0237-2018
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 Number AZ06682
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.