BEUDAMED
    FDA Recall Terminated

    Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of anti-thyroglobulin antibodies (TgAb) in human serum on specific TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis of autoimmune thyroid disorders, such as Graves disease and Hashimotos disease. Comment to IU: Please note that the Calibrator set is not part of the IU but required for the assay.

    Recall: Z-1187-2021 · Initiated February 23, 2012

    Recall

    Recall Number
    Z-1187-2021
    Event Number
    76372
    Firm
    Tosoh Bioscience Inc
    FEI Number
    3005529799
    Product Code
    JZO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 23, 2012
    Terminated
    July 8, 2021
    Address
    3600 Gantz Rd, Grove City, OH, 43123-1895

    Description

    Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of anti-thyroglobulin antibodies (TgAb) in human serum on specific TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis of autoimmune thyroid disorders, such as Graves disease and Hashimotos disease. Comment to IU: Please note that the Calibrator set is not part of the IU but required for the assay.

    Reason

    Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable.

    Action

    On 7/24/2012 the firm sent recall notificaiton letters to their customers.

    Distribution

    US Nationwide distribution in the states of CA, FL, GA, NY, OH & OR.

    Quantity

    34 boxess/2 sets/6 bottles