Events

Field Safety Notices about Alere INRatio® PT/INR Home Monitoring Kit (RT_Coagulation Hardware + accessories + consumables)

According to Ministry of Health, State Institute for Drug Control, Coordination Center for Departmental Medical Information Systems, this field safety notices involved a device in Czechia that was produced by Alere San Diego, Inc..

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event ID
    752
  • Date
    2016-09-16
  • Event Country
    Czechia
  • Event Source
    MHSIDCCCDMIS
  • Event Source URL
    https://eregpublicsecure.ksrzis.cz/Registr/RZPRO/FSN
  • Notes / Alerts
    Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, 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 the Czech Republic.
  • Extra notes in the data

Device

Alere INRatio® PT/INR Home Monitoring Kit (RT_Coagulation Hardware + accessories + consumables)
  • Model / Serial
    Catalog Number: all catalogue numbers (see attached list) Model Number: all models (see attached list) Serial Number: All Serial numbers Batch Number: all lot numbers
  • Product Classification
    Hematology and Pathology Devices
  • Product Description
    Diagnostic medical devices in vitro
  • Manufacturer
    Alere San Diego, Inc.

Manufacturer

Alere San Diego, Inc.
  • 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
    MHSIDCCCDMIS