Recalls / —
—#159890
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)
- FDA product code
- GKZ — Counter, Differential Cell
- Device class
- Class 2
- Medical specialty
- Hematology
- 510(k) numbers
- K140911
- Affected lot / code info
- Serial Number AZ06682
Why it was recalled
The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.
Root cause (FDA determination)
Device Design
Action the firm took
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."
Recalling firm
- Firm
- Beckman Coulter Inc.
- Address
- 250 S Kraemer Blvd, Brea, California 92821-6232
Distribution
- Distribution pattern
- CA, AR, HI, CA, OH, WA, MD, Canada, Japan
Timeline
- Recall initiated
- 2017-11-03
- Terminated
- 2018-06-19
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #159890. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.