Events

Recall of Device Recall INRatio Prothrombin Time (PT) Monitoring System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alere San Diego, Inc..

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
    74665
  • Event Risk Class
    Class 1
  • Event Number
    Z-2355-2016
  • Event Initiated Date
    2016-07-11
  • Event Date Posted
    2016-08-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148142
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Test, time, prothrombin - Product Code GJS
  • Reason
    Alere san diego is initiating a voluntary recall for the alere inratio¿/inratio¿2 pt/inr monitoring systems (test strips and meters). this action is being initiated as a result of patients who had a therapeutic or near-therapeutic inr with the alere inratio¿/inratio¿2 pt/inr monitoring system but a significantly higher inr (outside of therapeutic range) when performed by a central laboratory.
  • Action
    Alere issued a press release on July 11, 2016. An Urgent Medical Device Letter dated July 26, 2016 was sent to affected customers on July 29, 2016. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to consult with their healthcare provider as soon as possible to transition to an alternate method of PT/INR testing and to contact the firm regarding return or disposal of unused product and obtaining device replacement from a different manufacturer. For questions contact the Alere INRatid1 Recall Hotline at 1-866-723-2535.

Device

Device Recall INRatio Prothrombin Time (PT) Monitoring System
  • Model / Serial
    All Lots All Serial Numbers
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and foreign distribution to the countries of: Argentina, Australia, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Brunei Daruss, Canada, Chile, China, Colombia, Egypt, France, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Malaysia, Maldives, Netherlands, Russia, Rwanda, Singapore, South Africa, South Korea, Spain, Taiwan, Thailand, Trinidad, Ukraine, Uruguay, and Vietnam.
  • Product Description
    INRatio Prothrombin Time (PT) Monitoring System || Model Number: 0100007 || Product Usage: || The INRatio Prothrombin Time Monitoring System uses a modified version of the one-stage PT test. After a drop of blood is applied to the test strip, it is drawn into the test area and mixed with reagents that cause coagulation to begin. The test strip area on the test strip is separated into three channels, each of which contains electrodes for detection of the blood clot. One channel contains the reagents to perform the Prothrombin time test on the blood sample. The other two channels contain the reagents. to perfom the Prothrombin time test on the blood sample. The other two channels contain the reagents to run control tests. No external quality control test are required for the INRatio System. The meter monitors the reactions, and calculates the PT and INR for the blood sample, which are reported on the display. If the control results are not within a set range, it indicates a problem with the test and an error message is reported on the display instead of a result.
  • Manufacturer
    Alere San Diego, Inc.

Manufacturer

Alere San Diego, Inc.
  • Manufacturer Address
    Alere San Diego, Inc., 9975 Summers Ridge Rd, San Diego CA 92121-2997
  • 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
    USFDA