Z-0238-2018 Class II Terminated
FDA device recall Z-0238-2018 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: 3 units.
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
- 3 units
Product Description
UniCel DxH Slidemaker Stainer, Part Number 75222, for use with automated hematology analyzer
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 Numbers: AW09034, AV40142, AU19113