Events

Recall of Device Recall 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
    66842
  • Event Risk Class
    Class 2
  • Event Number
    Z-0547-2014
  • Event Initiated Date
    2013-11-08
  • Event Date Posted
    2013-12-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123724
  • 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
    Qualigen initiated this recall because the fastpack kit may cause lower than expected results due to a manufacturing defect.
  • Action
    Qualigen, Inc., notified customers of the recall by calling customers via telephone (with a telephone script) on 11/08/2013. The telephone (script) included the reason for recall, product description with codes, instructions and contact information. The customers were instructed to examine your inventory and discontinue use of the kits immediately. Qualigen will send you replacement kits and provide you with a shipping label to return all of the defective kits including any that were partially used. Feel free to contact System Support at 760.579.6900 if you have any questions or require assistance with returning your kits.

Device

Device Recall FastPack Total PSA Immunoassay
  • Model / Serial
    Total PSA: Catalog Number 25000040. Lot Number 1309038-10P Exp Date 6/26/2013.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.
  • Product Description
    FastPack Total PSA Immunoassay || Chemilunescence assay for the determination of Total PSA. || FastPack Total PSA Immunoassay 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 Total PSA Immunoassay is designed for use with the FastPack 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