BEUDAMED
    FDA Recall Terminated

    IgG Antisera component of the paragon Electrophoresis IFE Antisera Kit, a subcomponent of the Paragon Electrophoresis System Immunofixation (IFE) kit. Part Numbers: 446360 (250 test kit) 446260 (50 test kit) 444970 (10 test kit)

    Recall: Z-1149-04 · Initiated January 28, 2004

    Recall

    Recall Number
    Z-1149-04
    Event Number
    28965
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    CFF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 28, 2004
    Posted
    July 23, 2004
    Terminated
    August 30, 2004
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    IgG Antisera component of the paragon Electrophoresis IFE Antisera Kit, a subcomponent of the Paragon Electrophoresis System Immunofixation (IFE) kit. Part Numbers: 446360 (250 test kit) 446260 (50 test kit) 444970 (10 test kit)

    Reason

    Inconsistent and incomplete results for IgG.