Events

Recall of Alere INRatio / INRatio 2 PT/INR Monitoring System. An in vitro diagnostic medical device (IVD)

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-2016-RN-00999-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-08-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00999-1
  • 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
    In december 2014 (tga ref: rc-2014-rn-01289-1), alere initiated a correction to inform users of the alere inratio system that patients with certain medical conditions should not be tested with the system due to the potential, in certain cases, of the alere inratio system to provide an inr result that was significantly lower than a result obtained using a laboratory inr system. alere has recently decided to remove the alere inratio system from the market and to discontinue manufacturing the product line. alere will continue manufacturing and distributing the alere inratio test strips for a period of time to allow patients to safely transition to another monitoring method.
  • Action
    Alere is advising customers to transition to an alternative method to perform PT/INR testing as soon as possible. Alternate methods may include a plasma-based laboratory INR method or monitoring with a point-of-care system from a different manufacturer. After transitioning onto another system, the Alere system and remaining test strips must be returned to Alere. Customers can continue to use the Alere INRatio System until users have transitioned, as long as patients adhere to the precautions and recommendations found in the 2014 Recall for Product Correction letter and the current product insert. For further information, please see https://www.tga.gov.au/alert/alere-inratio-ptinr-monitor-system .

Device

Alere INRatio / INRatio 2 PT/INR Monitoring System. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Alere INRatio / INRatio 2 PT/INR Monitoring System. An in vitro diagnostic medical device (IVD)INRatio Prothrombin Time PT Monitoring SystemProduct Code: HS0100267INRatio 2 Professional Testing KitProduct Code: HS0200431INRatio 2 Home Monitoring KitProduct Code: HS0200433, HS0200433SJM, HS200433SJMKINRatio PT/INR Test StripsProduct Codes: HS0100071, HS0100139INRatio 2 PT/INR Test Strips Heparin-InsensitiveProduct Codes: HS99007G1, HS99008G1ARTG Number: 214252
  • Product Classification
    Hematology and Pathology Devices
  • Manufacturer
    Inverness Medical Innovations Australia Pty Ltd T/A Alere

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