BEUDAMED
    FDA Recall Terminated

    IMMAGE IGALC Reagent Part Number: 447460

    Recall: Z-1146-04 · Initiated June 6, 2003

    Recall

    Recall Number
    Z-1146-04
    Event Number
    28963
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    CFN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 6, 2003
    Posted
    July 23, 2004
    Terminated
    August 30, 2004
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    IMMAGE IGALC Reagent Part Number: 447460

    Reason

    Inconsistent results are obtained depending upon the matrix or sample source (plasma versus cerebrospinal fluid).