BEUDAMED
    FDA Recall Terminated

    Access Thyroglobulin Antibody II, Part Number: A32898 The Access Thyroglobulin Antibody II (TgAb) assay intended use is for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems.

    Recall: Z-1818-2011 · Initiated January 26, 2011

    Recall

    Recall Number
    Z-1818-2011
    Event Number
    57946
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    JNL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 26, 2011
    Posted
    March 24, 2011
    Terminated
    May 4, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92821-6208

    Description

    Access Thyroglobulin Antibody II, Part Number: A32898 The Access Thyroglobulin Antibody II (TgAb) assay intended use is for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems.

    Reason

    The recall was initiated after Beckman Coulter confirmed customer reports of reagent pack to pack variability for the Access Thyroglobulin Antibody II (TgAb) reagent lot numbers identified in the recall. Erroneous results for patient and quality control samples can be generated. The Thyroglobulin Antibody II (TgAbII) reagent lots may produce: (1) Erroneously high TgAb results for both quality co

    Action

    Beckman Coulter sent a Product Corrective Action (PCA) letter on January 26, 2011 via US Postal Service to the affected customers. The letter explained the problem identified and the action to be taken. Customers were instructed to: (1) Discontinue use of Access Thyroglobulin Antibody II reagent lot numbers identified in the table above; (2) If customers obtained questionable thyroglobulin antibody results, or received feedback from clinicians on reported thyroglobulin antibody results using the reagent lot numbers identified above, rerun or request a redraw of the patient sample; (3) Share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If they forwarded any of the affected product listed above to another laboratory, they should provide a copy of the letter to them; (4) Complete and return the enclosed response form within 10 days so the firm can be assured that you have received this important notification and are taking appropriate action. For questions regarding the recall communication, customers were told to contact Beckman Coulter Customer Support Center: (1) Via our website, http://www.beckmancoulter.com/customersupport/support (2) Via phone, call 1-800-854-3633 in the United States and Canada (3) Outside the United States and Canada please contact your local Beckman Coulter representative.

    Distribution

    Worldwide Distribution - USA including AR, CA, FL, GA, HI, IA, IL, KY, MA, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI and the countries of Argentina, Armenia, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, France, French Polynesia, Georgia, Germany, Greece, Hungary, Israel, Italy, Kazakhstan, Kuwait, Lebanon, Morocco, Netherlands, New Zealand, Oman, Poland, Puerto Rico, Romania, Russian Federation, Serbia, South Africa, Spain, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, United Arab Emirates, Yemen

    Quantity

    3658 units (1800 in US)