BEUDAMED
    FDA Recall Terminated

    UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029. Beckman Coulter, Inc. Brea, CA. Quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.

    Recall: Z-1680-2010 · Initiated December 8, 2009

    Recall

    Recall Number
    Z-1680-2010
    Event Number
    55462
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 8, 2009
    Posted
    May 26, 2010
    Terminated
    June 4, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92821-6208

    Description

    UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029. Beckman Coulter, Inc. Brea, CA. Quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.

    Reason

    The Corrective Action was initiated after Beckman Coulter confirmed three issues related to host transmissions with the UniCel DxH 800. This information only affects instruments interfaced to a host system.

    Action

    Beckman Coulter, Inc. issued an "Urgent: Product Corrective Action" notification dated December 8, 2009. Consignees were informed of the affected product and provided temporary solutions until further support will be made available. For additional information, contact your local Beckman Coulter Representative or call 800-526-7694.

    Distribution

    Distributed Nationwide and Canada.

    Quantity

    42 units (40 in US)