—#159889

Product

UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K140911
Affected lot / code info: Serial Numbers: B24802: AW10161, AW10154, AZ34449, AZ34447 629029: AT40563, AT06096, AT06095, AT02044, AW05080, AW05072, AW05066, AT50679, AS49422, AS36312, AS23151

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 #159889. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.