Safety Alert for i-STAT PT/INR Cartridge

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Abbott Point of Care Division.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
  • Event Date Posted
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: abbott i-stat pt/inr cartridge the therapeutic goods administration (tga), australia issued a medical device safety alert concerning i-stat pt/inr cartridge, manufactured by abbott point of care division. the affected list number is 3p89-24, and the affected lot numbers are 1 c103139 to and including c13270a. 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. the manufacture advises users to destroy unused stock. any remaining stock will be replaced by abbott. also, the manufacturer advises that a review of previous results may be performed at the discretion of the laboratory manager. for details, please refer to tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-01119-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 4 november 2013.



  • Manufacturer Parent Company (2017)
  • 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