Events

Recall of Device Recall Qualigen FastPack IP Vitamin D Immunoassay Kit Complete

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Qualigen Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77726
  • Event Risk Class
    Class 2
  • Event Number
    Z-3112-2017
  • Event Initiated Date
    2017-07-07
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157763
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, test, vitamin d - Product Code MRG
  • 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: babugan@qualigeninc.com or nsomera@qualigenic.com 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.

Device

Device Recall Qualigen FastPack IP Vitamin D Immunoassay Kit Complete
  • Model / Serial
    Lot numbers: 1701033-3P, 1701033-4P, 1701033-5P, and 1701033-6P
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide) and to countries of: Germany, Switzerland, turkey and UAE.
  • Product Description
    Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 || Vitamin D immunoassay kit
  • Manufacturer
    Qualigen Inc

Manufacturer

Qualigen Inc
  • Manufacturer Address
    Qualigen Inc, 2042 Corte Del Nogal, Carlsbad CA 92011-1438
  • Manufacturer Parent Company (2017)
    Qualigen Inc
  • Source
    USFDA