BEUDAMED
    FDA Recall 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 · Initiated November 8, 2013

    Recall

    Recall Number
    Z-0548-2014
    Event Number
    66842
    Firm
    Qualigen Inc
    FEI Number
    3003355251
    Product Code
    CDZ
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    November 8, 2013
    Posted
    December 19, 2013
    Terminated
    September 18, 2014
    Address
    2042 Corte del Nogal, Carlsbad, CA, 92011-1438

    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.

    Action

    Qualigen, Inc., notified customers of the recall by calling customers via telephone (with a telephone script) on 11/08/2013. The telephone (script) included the reason for recall, product description with codes, instructions and contact information. The customers were instructed to examine your inventory and discontinue use of the kits immediately. Qualigen will send you replacement kits and provide you with a shipping label to return all of the defective kits including any that were partially used. Feel free to contact System Support at 760.579.6900 if you have any questions or require assistance with returning your kits.

    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