Events

Recall of i-STAT PT/INR Cartridge (prothrombin time test used for monitoring patients receiving oral anticoagulation therapy) (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 Abbott Australasia Pty Ltd (Point-of-Care Division).

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-2013-RN-01119-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-11-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01119-1
  • 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
    Abbott point of care has determined that the i-stat pt/inr cartridge lots have the potential to exhibit incorrectly elevated results. internal studies have demonstrated that i-stat pt/inr results are elevated by an average of approximately 10% as compared to the international reference preparation (rtf/09) in the therapeutic range of 1.8 to 3.0 inr.
  • Action
    Abbott Diagnostic is advising users to destroy unused stock. Any remaining stock will be replaced by Abbott. A review of previous results may be performed at the discretion of the laboratory manager.

Device

i-STAT PT/INR Cartridge (prothrombin time test used for monitoring patients receiving oral antico...
  • Model / Serial
    i-STAT PT/INR Cartridge (prothrombin time test used for monitoring patients receiving oral anticoagulation therapy) (An in vitro diagnostic medical device (IVD))List Number: 3P89-24Lot Numbers: C103139 to and including C13270AARTG Number: 213851
  • Manufacturer
    Abbott Australasia Pty Ltd (Point-of-Care Division)

Manufacturer

Abbott Australasia Pty Ltd (Point-of-Care Division)
  • 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