BEUDAMED
    FDA Enforcement Class II Terminated

    FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone The FastPack Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of total testosterone in human serum and plasma. It is intended strictly for in-vitro diagnostic use as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen. The FastPack Testo Immunoassay is designed for use with the FastPack System.

    Recall: Z-0548-2014 · Reported December 25, 2013

    Enforcement

    Recall Number
    Z-0548-2014
    Event ID
    66842
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Qualigen Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    December 25, 2013
    Initiation Date
    November 8, 2013
    Classification Date
    December 19, 2013
    Termination Date
    September 18, 2014
    Address
    2042 Corte del Nogal, N/A, Carlsbad, CA, 92011-1438, United States

    Description

    FastPack Testosterone Immunoassay Chemilunescence assay for the determination of Testosterone The FastPack Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of total testosterone in human serum and plasma. It is intended strictly for in-vitro diagnostic use as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen. The FastPack Testo Immunoassay is designed for use with the FastPack System.

    Reason

    Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.

    Code Info

    Testosterone. Catalog Number 25000041. Lot Number 1310019-3P Exp Date: 9/22/2014

    Distribution

    US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.

    Quantity

    18