Events

Recall of ONE STEP AMPHETAMINE TEST - STRIP FORMAT AMP-S

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by IND DIAGNOSTIC 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
    18352
  • Event Risk Class
    II
  • Event Initiated Date
    2014-04-25
  • Event Country
    Canada
  • 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
    To ensure that all ind diagnostic canadian customers are aware that ind's medical device licences were suspended on february 8 2013 and therefore sale of the affected devices is prohibited in canada.

Device

ONE STEP AMPHETAMINE TEST - STRIP FORMAT AMP-S
  • Model / Serial
    Model Catalog: (Lot serial: -contact mfg)
  • Product Description
    One-Step Amphetamine Test (Strip Format)
  • Manufacturer
    IND DIAGNOSTIC INC.

Manufacturer

IND DIAGNOSTIC INC.