BEUDAMED
    FDA Recall Terminated

    Coulter AcT 5diff Open Vial Hematology Analyzers Part Numbers: 6605580, 6605581, 6605604

    Recall: Z-0039-04 · Initiated September 8, 2003

    Recall

    Recall Number
    Z-0039-04
    Event Number
    27251
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 8, 2003
    Posted
    October 15, 2003
    Terminated
    March 30, 2004
    Address
    200 South Kraemer Blvd W, 337, Brea, CA, 92822

    Description

    Coulter AcT 5diff Open Vial Hematology Analyzers Part Numbers: 6605580, 6605581, 6605604

    Reason

    Samples with high fat content will not count platelets accurately.

    Action

    Firm issued an advisory letter to users to retain as part of the Quality Manual for the instruments. It cautions to check specimens for interfering lipemia. Letter was sent 9/8/2003.

    Distribution

    United States and Canada

    Quantity

    36