BEUDAMED
    FDA Recall Terminated

    Access Immunoassay Systems Thyroglobulin Antibody Reagent Kit, Part Number 33890

    Recall: Z-0417-2007 · Initiated October 26, 2006

    Recall

    Recall Number
    Z-0417-2007
    Event Number
    37065
    Firm
    Beckman Coulter Inc
    FEI Number
    2050012
    Product Code
    DDC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 26, 2006
    Posted
    February 7, 2007
    Terminated
    April 30, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92822-6208

    Description

    Access Immunoassay Systems Thyroglobulin Antibody Reagent Kit, Part Number 33890

    Reason

    Low end imprecision affecting both S0 calibrators and patient samples which can lead to inaccurate low level patient results when using the Access Thyroglobulin Antibody assay.

    Action

    A Product Corrective Action (PCA) letter was mailed on Oct 27, 2006 to all Thyroglobulin Antibody customers. They are informed that there has been an increase in customer feedback regarding low end imprecision affecting both S0 calibrators and patient samples, which can lead to inaccurate low level patient results when using the Access Thyroglobulin Antibody assay. The letter informs the customer that the firm recommends that they use an alternate method for testing TgAb. (Letter was sent by US mail). Customers are asked to complete and return the enclosed response form within 10 days.

    Distribution

    Nationwide and Canada

    Quantity

    474 units