Z-0237-2018 Class II Terminated
FDA device recall Z-0237-2018 was initiated by Beckman Coulter Inc. on November 3, 2017 and is designated Class II. Reason for recall: The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position. The recall status is terminated (terminated June 19, 2018). Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- December 20, 2017
- Initiation Date
- November 3, 2017
- Termination Date
- June 19, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
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)
Reason for Recall
The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.
Distribution Pattern
CA, AR, HI, CA, OH, WA, MD, Canada, Japan
Code Information
Serial Number AZ06682