BEUDAMED
    FDA Recall Terminated

    IMMAGE IgM Reagent Part No.: 447610

    Recall: Z-1150-04 · Initiated June 6, 2003

    Recall

    Recall Number
    Z-1150-04
    Event Number
    29094
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    DEW
    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 IgM Reagent Part No.: 447610

    Reason

    low level IgM serum sample results may be suppressed and an error code generated when using affected lots. Error codes are seen as E60 or E66.

    Quantity

    10,000