Events

Recall of FastPack Total PSA 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
    50115
  • Event Risk Class
    Class 2
  • Event Number
    Z-0500-2009
  • Event Date Posted
    2008-12-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74758
  • 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
    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers - Product Code LTJ
  • Reason
    The recall was initiated after the firm investigation of customer complaints of falsely elevated results determined the product was not meeting product performance expectations.
  • Action
    The recall was initiated with Qualigen faxing a copy of the Product Notification letter, dated 9/29/2008, to all customers who have received any sublot of the affected product . Faxes were sent beginning 9/29/08. The recall letter informed the customers that the affected product was not meeting the firm's expectations for product performance. Customers were instructed to please stop using the affected lots immediately as they have been noted to produce falsely elevated results and they should confirm any result that appears to be inconsistent with "a patient's medical history, clinical examination, and other findings". In addition, they may wish to retest any patients that were run with a different FastPack lot. Beginning on 9/30/08, all customers were contacted by phone to confirm that they received the recall letter. The customers were shipped replacement products at no cost and as part of the product replacement process, they were instructed to return any unused Total PSA FastPacks/Kits of lot 0807002 to Qualigen.

Device

FastPack Total PSA Immunoassay
  • Model / Serial
    Lot Numbers: 0807002-901, 0807002-903, 0807002-904, 0807002-905, 0807002-906, 0807002-907, 0807002-908, and 0807002-909.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of Canada, UK , Italy, Switzerland, Sweden, & South Korea.
  • Product Description
    FastPack(R) Total PSA Immunoassay; Catalog #: 25000001 || 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(R) Total PSA immunoassay is designed for use with the FastPack (R) System.
  • 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