Events

Recall of Alere INRatio2 PT/INR Heparin Insensitive Test Strips

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Inverness Medical Innovations Australia Pty Ltd T/A Alere.

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
    RC-2014-RN-00471-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-05-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00471-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    This action is being initiated as a result of post-market surveillance information in the united states (usa), where it has been noted that in rare circumstances patients who return a therapeutic or near therapeutic inr result using the alere inratio2 pt/inr heparin insensitive test strips have had a significantly higher inr (outside of the therapeutic range) when performed within 1 hour to 1 day by a central laboratory.
  • Action
    Alere is notifying healthcare providers of an update to the limitations of use for the INRatio 2 PT/INR tests strips. Additionally, consumers are being provided with a Safety Alert notification advising of potential issues with the accuracy of the device and the correct clinical practice with regard to medication dosing. For more details, please see http://www.tga.gov.au/safety/alerts-device-alere-inratio2-140508.htm

Device

Alere INRatio2 PT/INR Heparin Insensitive Test Strips

Manufacturer

Inverness Medical Innovations Australia Pty Ltd T/A Alere
  • 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
    DHTGA