Events

Recall of FastPack Total Testosterone Immunoassay

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
    27562
  • Event Risk Class
    Class 2
  • Event Number
    Z-0090-04
  • Event Initiated Date
    2003-09-19
  • Event Date Posted
    2003-11-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-03-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30085
  • 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
    Radioimmunoassay, Testosterones And Dihydrotestosterone - Product Code CDZ
  • Reason
    Kits may produce results that are falsely elevated.
  • Action
    All customers who received any one of the three lots have been faxed a removal letter starting 09/24/03. Certified or Airborne letter sent on 09/29/03.

Device

FastPack Total Testosterone Immunoassay
  • Model / Serial
    Lots: 0307042, 0308019, and 0308020 Catalog #: 25000009
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide and Switzerland.
  • Product Description
    Device to determine quantitative total testosterone in human serum
  • Manufacturer
    Qualigen Inc

Manufacturer

Qualigen Inc
  • Manufacturer Address
    Qualigen Inc, 2042 Corte Del Nogal, Carlsbad CA 92009-1438
  • Source
    USFDA