Recall Z-0238-2018
Beckman Coulter Inc. · initiated November 3, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
UniCel DxH Slidemaker Stainer, Part Number 75222, for use with automated hematology analyzer
Codes / lots: Serial Numbers: AW09034, AV40142, AU19113
Reason for recall
The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.
FDA-determined cause: Device Design
Action taken
The firm notified its consignees of the recall on 11/03/2017 by letter. The letter stated the issue and provided the following instructions: "To avoid a biohazardous spill, do not use the right (green) position of the Single-Tube Station for sample aspiration until the shield is removed. You may remove the shield following the instructions in Attachment 1 or contact your local Beckman Coulter Representative for further assistance."
Details
- Recall number
- Z-0238-2018
- Initiated
- November 3, 2017
- Terminated
- June 19, 2018
- Product code
- GKZ – Counter, Differential Cell
- Quantity
- 3 units
- Distribution
- CA, AR, HI, CA, OH, WA, MD, Canada, Japan
- Recalling firm
- Beckman Coulter Inc., Brea, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0236-2018 Class II | UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzerThe shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the… | 11/03/2017Terminated |
| Z-0237-2018 Class II | UniCel DxH600, Part Number B23858, automated hematology analyzer (Note: the DxH 600 is…The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the… | 11/03/2017Terminated |