BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0236-2018 · Reported December 20, 2017

    Enforcement

    Recall Number
    Z-0236-2018
    Event ID
    78611
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beckman Coulter Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 20, 2017
    Initiation Date
    November 3, 2017
    Classification Date
    December 13, 2017
    Termination Date
    June 19, 2018
    Address
    250 S Kraemer Blvd, N/A, Brea, CA, 92821-6232, United States

    Description

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

    Reason

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

    Code Info

    Serial Numbers: B24802: AW10161, AW10154, AZ34449, AZ34447 629029: AT40563, AT06096, AT06095, AT02044, AW05080, AW05072, AW05066, AT50679, AS49422, AS36312, AS23151

    Distribution

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

    Quantity

    15 units