Events

Recall of Device Recall HemoSense INRatio2

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by HemoSense 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
    50695
  • Event Risk Class
    Class 3
  • Event Number
    Z-1256-2009
  • Event Initiated Date
    2008-12-23
  • Event Date Posted
    2009-05-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76159
  • 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
    Inratio monitors that were manufactured with a specific eeprom memory chip fail during use. the monitors report an error code and do not report a test result.
  • Action
    Letters for each product titled "Urgent: Medical Device Recall Notice" dated December 19, 2008 were issued explaining the problem and instructing users to discontinue use, complete the provided reply form and return the device by mail to Inverness Medical. Distributors of the violative device were instructed to contact their customers and provide the same recall information. Further questions should be addressed to HemoSense Technical Service at 1-877-441-7440.

Device

Device Recall HemoSense INRatio2
  • Model / Serial
    Product Numbers: 0200431 and 0200432.
  • Product Classification
    Hematology and Pathology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution in the US, Germany, Spain and Australia.
  • Product Description
    HemoSense INRatio2 Prothrombin Time Monitor, manufactured by HemoSense Incorporated. || The INRatio2 PT Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood.
  • Manufacturer
    HemoSense Inc

Manufacturer

HemoSense Inc
  • Manufacturer Address
    HemoSense Inc, 651 River Oaks Pkwy, San Jose CA 95134-1907
  • 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