Recall of DRUGCHECK 2 PANEL DIPS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by EXPRESS DIAGNOSTICS INTERNATIONAL 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
    50979
  • Event Risk Class
    III
  • Event Initiated Date
    2011-06-27
  • Event Country
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Distributed product into canada without license.

Device

  • Model / Serial
    Model Catalog: 30200 (Lot serial: 200 020311); Model Catalog: 30200 (Lot serial: 200 012411); Model Catalog: 70610 (Lot serial: 610 042111); Model Catalog: 60500 A (Lot serial: a500 022111); Model Catalog: 60500 A (Lot serial: A500 040711); Model Catalog: 60505 (Lot serial: 505 031911); Model Catalog: 60505 (Lot serial: 505 032311); Model Catalog: 60505 (Lot serial: 505 022511); Model Catalog: 61020 (Lot serial: 020 021411)
  • Product Description
    DRUGCHECK 2 PANEL DIPS
  • Manufacturer

Manufacturer