BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-3112-2017 · Initiated July 7, 2017

    Recall

    Recall Number
    Z-3112-2017
    Event Number
    77726
    Firm
    Qualigen Inc
    FEI Number
    3003355251
    Product Code
    MRG
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 7, 2017
    Terminated
    October 22, 2018
    Address
    2042 Corte Del Nogal, Carlsbad, CA, 92011-1438

    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

    Action

    The firm, Qualigen, sent an "URGENT: PRODUCT RECALL" letter dated 7/5/2017 to its customers by email or fax on 07/07/2017. The letter described the product, problem and actions to be taken. The customers were instructed to stop using the products immediately; discard any product remaining in your inventory; and complete, sign and return the attached CONFORMATION OF NOTIFICATION form by email to: [email protected] or [email protected] or fax to: 760-918-9127 by 7/15/2017. Please contact System Support at 877-709-2169, Option #2 if you need further assistance.

    Distribution

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

    Quantity

    493 units