BEUDAMED
    FDA Recall Terminated

    AEROSET Immunoglobulin M, list number 1E01-01, manufactured by Abbott Laboratories, South Pasadena, CA

    Recall: Z-0165-04 · Initiated July 31, 2002

    Recall

    Recall Number
    Z-0165-04
    Event Number
    27178
    Firm
    Abbott Laboratories Diagnostic Div
    FEI Number
    2018433
    Product Code
    DFT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 31, 2002
    Posted
    July 20, 2004
    Terminated
    November 26, 2003
    Address
    820 Mission Street, South Pasadena, CA, 91030

    Description

    AEROSET Immunoglobulin M, list number 1E01-01, manufactured by Abbott Laboratories, South Pasadena, CA

    Reason

    Assay may produce falsely low IgM results without error codes when testing specimens contain elevated serum paraproteins associated with various myeloma or other malignancies.

    Action

    Consignees were provided with assay parameters for the RCD flag which may enhance the detection of these type of specimens. The assay parameter settings for the RCD flag were distributed to all AEROSET consignees in the United States by direct mail and to country managers worldwide via a Product Information letter dated July 31, 2002. Also provided with the Product Information letter was an AEROSET IgM Application Sheet containing the updated assay parameters for the RCD flag.

    Distribution

    Nationwide to the following states: Texas, Illinois, Indiana, Tennessee, Alaska, Pennsylvania, New York, Florida, Massachusetts, Missouri, Alabama, North Carolina, California, Ohio, Utah, Michigan, Arizona, Wisconsin, Oklahoma, Maine, Kansas, Georgia, Mississippi, Connecticut, Rhode Island, Washington, Wyoming, Louisiana, Washington, Maryland, New Jersey, Arkansas, Iowa, South Carolina, Colorado, Minnesota, North Dakota, and West Virginia. Worldwide to the following countries: Argentina, Australia, Brazil, Germany, England, Canada, Chile, Colombia, Dominican Republic, Denmark, France, Hong Kong, Japan, Korea, Singapore, Guatemala, New Zealand, Thailand, Turkey, Spain, Italy, South Africa, Sweden, Greece, Portugal, Venezuela, Pakistan, Finland, Ireland, and Taiwan.

    Quantity

    205 units