BEUDAMED
    FDA Enforcement Class II Terminated

    The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding Globulin in human serum and plasma on the FastPack System. The FastPack IP SHBG assay is intended for use as an aid in the diagnosis of androgen disorders. Each Kit Contains 30 FastPack IP SHBG Immunoassays 1 Calibrator 1 x 3 mL Vial 1 Control 1 1 x 3 mL Vial 1 Control 2 1 x 3 mL Vials 32 Sample Diluent 0.9 mL Vials REF 25000081 IVD CE 1908038-1P 2020-02-22 (01) 20816467020345 (17) 200222 (10) 1908038-1P

    Recall: Z-1672-2020 · Reported April 15, 2020

    Enforcement

    Recall Number
    Z-1672-2020
    Event ID
    85134
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Qualigen Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 15, 2020
    Initiation Date
    November 6, 2019
    Classification Date
    April 6, 2020
    Termination Date
    September 23, 2020
    Address
    2042 Corte Del Nogal, N/A, Carlsbad, CA, 92011-1438, United States

    Description

    The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative Measurement of SHBG is a chemiluminescent immunoassay intended for the quantitative determination of Sex Hormone Binding Globulin in human serum and plasma on the FastPack System. The FastPack IP SHBG assay is intended for use as an aid in the diagnosis of androgen disorders. Each Kit Contains 30 FastPack IP SHBG Immunoassays 1 Calibrator 1 x 3 mL Vial 1 Control 1 1 x 3 mL Vial 1 Control 2 1 x 3 mL Vials 32 Sample Diluent 0.9 mL Vials REF 25000081 IVD CE 1908038-1P 2020-02-22 (01) 20816467020345 (17) 200222 (10) 1908038-1P

    Reason

    The chemiluminescent immunoassay has been noted to have higher than expected results which may result in inaccurate quantitative determinations of Sex Hormone Binding Globulin in human serum and plasma.

    Code Info

    1908038-1P 2020-02-22 (01) 20816467020345 (17) 200222 (10) 1908038-1P

    Distribution

    US Nationwide distribution in the states of AL, AK, CA, HI, and TX.

    Quantity

    24 Kits (30 test packs each) 720 tests