BEUDAMED
    FDA Enforcement Class II Terminated

    FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. The FastPack Total PSA Immunoassay is designed for use with the FastPack System.

    Recall: Z-0547-2014 · Reported December 25, 2013

    Enforcement

    Recall Number
    Z-0547-2014
    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 Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. The FastPack Total PSA 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

    Total PSA: Catalog Number 25000040. Lot Number 1309038-10P Exp Date 6/26/2013.

    Distribution

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

    Quantity

    182