BEUDAMED
    FDA Recall Terminated

    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)

    Recall: Z-0237-2018 · Initiated November 3, 2017

    Recall

    Recall Number
    Z-0237-2018
    Event Number
    78611
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 3, 2017
    Terminated
    June 19, 2018
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    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

    The shield for the Single-Tube Station on the DxH instrument may interfere with sample aspiration in the open vial position.

    Action

    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."

    Distribution

    CA, AR, HI, CA, OH, WA, MD, Canada, Japan

    Quantity

    1 unit