Events

Recall of Alere INRatio & INRatio2 PT/INR Monitor 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-2014-RN-01289-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-12-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01289-1
  • 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 certain cases an inratio & inratio2 pt/inr monitor system may provide an inr result that is clinically significantly lower than a result obtained using a reference inr system (laboratory method). this issue can arise if the patient has certain medical conditions.Br /br /further information has been published on the tga website at - http://www.Tga.Gov.Au/alert/alere-inratio-ptinr-monitor-system .
  • Action
    Alere is advising consumers and healthcare professionals of the additional warnings and precautions required when using the INRatio & INRatio2 PT/INR Monitor systems. Consumers are requested to consult their doctor to determine if any of the following conditions apply to them: - Anaemia (haematocrit < 30%) - chronic inflammatory conditions - severe infection - advanced stage cancer or end stage renal disease - any bleeding or unusual bruising. This action has beenclosed-out on 06/07/2016.

Device

Alere INRatio & INRatio2 PT/INR Monitor System. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Alere INRatio & INRatio2 PT/INR Monitor System. An in vitro diagnostic medical device (IVD)INRatio Test Strips Reference Numbers: HS0100071, HS0100139, HS099007EU, HS99007G1, HS099008EU, HS99008G1Multiple Product DescriptionsARTG Number: 216755INRatio2 Monitors Reference Numbers: HS0200431, HS200433SJM, HS200433SJMK, HS0200433Multiple Product DescriptionsARTG 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