Events

Recall of Device Recall Dengue IgG/IgM

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
    Recall
  • Event ID
    67665
  • Event Risk Class
    Class 2
  • Event Number
    Z-1340-2014
  • Event Initiated Date
    2014-03-04
  • Event Date Posted
    2014-04-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125965
  • 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.

Device

Device Recall Dengue IgG/IgM
  • Model / Serial
    Catalog number: 71019, All lots
  • Distribution
    Distributed in the states of CA, FL, NJ, TX, and NY.
  • Product Description
    Dengue IgG/IgM; || LumiQuick, || Santa Clara, CA 95054
  • Manufacturer
    LumiQuick Diagnostics Inc.

Manufacturer

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