BEUDAMED
    FDA Recall Terminated

    COULTER LH 700 Series Hematology Analyzers

    Recall: Z-0415-03 · Initiated November 8, 2002

    Recall

    Recall Number
    Z-0415-03
    Event Number
    25104
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 8, 2002
    Posted
    January 9, 2003
    Terminated
    July 17, 2003
    Address
    200 South Kraemer Blvd W, 337, Brea, CA, 92822

    Description

    COULTER LH 700 Series Hematology Analyzers

    Reason

    Software vote out logic changed. Erroneous white blood cell counts.

    Action

    Customers received a telephone call and a faxed Product Corrective Action letter dated Nov. 8, 2002 which includes modified operating instructions. Additionally an updated software version was released and installed on all affected customers units. This recall is complete.

    Distribution

    Nationwide and Canada

    Quantity

    132