Recall of Device Recall Fentanyl Test Card

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by LumiQuick Diagnostics 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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
  • Reason
    Products shipped to us locations that do not have approved applications for pma , ide or 510(k) clearance.
  • Action
    Urgent Device Recall notification letters were sent to all US consignees on March 4, 2014 by e-mail and US mail as well as a phone call. The letter identified the products and actions to be taken by the customers.


  • Model / Serial
    Catalog number: 74058, All lots
  • Distribution
    Distributed in the states of CA, FL, NJ, TX, and NY.
  • Product Description
    Fentanyl Test Card; || LumiQuick,. || Santa Clara, CA 95054
  • Manufacturer


  • Manufacturer Address
    LumiQuick Diagnostics Inc., 2946 Scott Blvd, Santa Clara CA 95054-3312
  • Manufacturer Parent Company (2017)
  • Source