BEUDAMED
    FDA Recall Terminated

    Beckman Coulter Access Thyroglobulin Antibody II Reagent, 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-2355-2010 · Initiated June 29, 2010

    Recall

    Recall Number
    Z-2355-2010
    Event Number
    56214
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    JNL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 29, 2010
    Posted
    September 2, 2010
    Terminated
    May 4, 2012
    Address
    200 S Kraemer Blvd, Brea, CA, 92821-6208

    Description

    Beckman Coulter Access Thyroglobulin Antibody II Reagent, 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 affected Access Thyroglobulin Antibody II reagent may produce inaccurate results due to a change in the thyroglobulin that was used in the kits.

    Action

    Beckman Coulter sent an "Urgent Product Corrective Action" letter dated June 29, 2010, with attached Customer Response form to the affected customers. The letter identified the affected product and issue. Customers were instructed to: (1) Discontinue use of Access Thyroglobulin Antibody II reagent lot numbers 916271, 917073, and 918433. (2) Review results in the context of the total clinical presentation of the patient, and rerun questionable results using another reagent. (3) Complete and return a response form within 10 days. (4) For replacement contact Beckman Coulter at (US) 1-800-526-3821, (Canada) 1-800-463-7828. Customer Technical Support can be contacted at 1-800-854- 3633.

    Distribution

    Worldwide distribution : United States, including states of CA, CO, FL, GA. IA, IL, KY, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI, and country of Canada.

    Quantity

    1071 units