BEUDAMED
    FDA Enforcement Class II 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 · Reported December 20, 2017

    Enforcement

    Recall Number
    Z-0237-2018
    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 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.

    Code Info

    Serial Number AZ06682

    Distribution

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

    Quantity

    1 unit