BEUDAMED
    FDA Enforcement Class II Terminated

    UniCel DxH Slidemaker Stainer, Part Number 75222, for use with automated hematology analyzer

    Recall: Z-0238-2018 · Reported December 20, 2017

    Enforcement

    Recall Number
    Z-0238-2018
    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 DxH Slidemaker Stainer, Part Number 75222, for use with 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: AW09034, AV40142, AU19113

    Distribution

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

    Quantity

    3 units