Events

Safety Alert for Alere INRatio2 PT/INR Professional Test Strips

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

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
    2014-05-07
  • Event Date Posted
    2014-05-07
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140507.html
  • 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: alere inratio2 pt/inr professional test strips the u.S. food and drug administration (fda) and the australia therapeutic goods administration (tga) posted a medical device safety alert concerning inratio2 pt/inr professional test strips, manufactured by alere. there were complaints of patients who had a therapeutic or near therapeutic inr with the alere inratio2 pt/inr professional test strip but a significantly higher inr (outside of therapeutic range) when performed by a central laboratory. the manufacturer has received nine serious adverse event reports, three of which described bleeding associated with patient deaths. the reason for the adverse event reports was significantly different test results between the alere inratio2 pt/inr professional test strip and the local laboratory plasma inr test. the alere inratio2 pt/inr professional test strip results were between 3.1 – 12.2 inr units lower than the laboratory result. there may be risk of inaccurately low inr result. the manufacturer has advised users to immediately stop using the alere inratio2 pt/inr professional test strips. it has also advised users to use an alternative method to perform pt/inr testing, such as a plasma-based laboratory inr test, an alternative alere product, or an alternative point-of-care monitoring system from a different manufacturer. the manufacturer is notifying healthcare providers of an update to the limitations of use for the inratio 2 pt/inr tests strips. 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. furthermore, the manufacturer will transition customers from the current alere inratio2 pt/inr professional test strip to the alere inratio pt/inr test strip (pn 100139). professional test strip to the alere inratio pt/inr test strip (pn 100139). for details, please refer to: the fda website http://www.Fda.Gov/safety/recalls/ucm396219.Htm and the tga website http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00471-1 if you are in possession of the product, please contact your supplier for necessary actions. posted on 7 may 2014.

Device

Alere INRatio2 PT/INR Professional Test Strips

Manufacturer

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
    DH