BEUDAMED
    FDA Enforcement Class II Terminated

    Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit

    Recall: Z-3112-2017 · Reported September 13, 2017

    Enforcement

    Recall Number
    Z-3112-2017
    Event ID
    77726
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Qualigen Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 13, 2017
    Initiation Date
    July 7, 2017
    Classification Date
    September 7, 2017
    Termination Date
    October 22, 2018
    Address
    2042 Corte Del Nogal, N/A, Carlsbad, CA, 92011-1438, United States

    Description

    Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit

    Reason

    Specific lots have been reported to produce falsely lower than expected results for Vitamin D

    Code Info

    Lot numbers: 1701033-3P, 1701033-4P, 1701033-5P, and 1701033-6P

    Distribution

    Worldwide Distribution: US (Nationwide) and to countries of: Germany, Switzerland, turkey and UAE.

    Quantity

    493 units