Events

Recall of INRATIO 2 PROTHROMBIN TIME (PT) MONITORING SYSTEM SELF-TEST

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ALERE CANADA.

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
    40653
  • Event Risk Class
    I
  • Event Initiated Date
    2016-07-20
  • 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
    Alere is withdrawing the alere inratio and inratio 2 prothrombin time (pt) monitoring systems (professional use and patient self-test) devices from the canadian market. there is a risk in certain cases that the alere devices provide an inaccurate low reading. alere with the best interest of patient safety in mind has decided to voluntarily remove the alere inratio system from the market and to discontinue manufacturing the product line. alere will continue manufacturing and distributing the inratio test strips for a period of time to allow patients to safely transition to another monitoring method. alere advises that users of the inratio system transition as soon as possible to an alternate method to perform pt/inr testing such as a plasma-based laboratory inr or a point of care monitoring system from a different manufacturer. until such time that a facility has transitioned to an alternate method of pt/inr testing they may continue to use the alere inratio system as long as they ensure that the facility and their patients (either patients being tested at their facility or their patients who self-test at home) adhere to the precautions and recommendations found in the medical device correction notification of december 2014 and current product insert labeling. these are available at www.Inr-care.Com or by calling alere at 1-877-866-5313.

Device

INRATIO 2 PROTHROMBIN TIME (PT) MONITORING SYSTEM SELF-TEST
  • Model / Serial
    Model Catalog: 0200433 (Lot serial: ALL); Model Catalog: 0200431 (Lot serial: ALL); Model Catalog: 0100139 (Lot serial: ALL); Model Catalog: 0100071 (Lot serial: ALL)
  • Product Classification
    Hematology and Pathology Devices
  • Product Description
    INRATIO 2 PROTHROMBIN TIME (PT) MONITORING SYSTEM SELF-TEST;INRATIO 2 PROTHROMBIN TIME (PT) MONITORING SYSTEM PROFESSIONAL;INRATIO/INRATIO 2 PROTHROMBIN TIME/INR TEST STRIPS
  • Manufacturer
    ALERE CANADA

Manufacturer

ALERE CANADA
  • Manufacturer Address
    OTTAWA
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    HC