Events

Safety Alert for Trade name: InRatio 2 Monitoring System Technical Name: Self-Test for Coagulation Parameters ANVISA Registration Number: 10071770848 Hazard Class: III Model Affected: Monitor InRatio2 Pro / Monitor InRatio2

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Alere S.A.; Alere San Diego, Inc..

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
  • Event ID
    2135
  • Date
    2016-09-21
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Extra notes in the data
    Product pickup. Attached communiqué
  • Reason
    In 2014, alere initiated a voluntary correction to inform users of the alreine time monitoring system inratio and inratio2 that patients with certain medical conditions should not be tested with the system. as part of its commitment to patient safety, alere proactively reported these concerns with the device to the fda and began conducting a comprehensive investigation of these events. over the past two years, alere has invested in the research and development of software enhancements to address the potential of the system. although alere is confident that the software enhancements it has developed and submitted to the fda in late 2015 address this problem effectively, the fda has notified the company that it believes the company's studies do not adequately demonstrate the effectiveness of the software modification and advised alere to submit a proposal for a plan to voluntarily remove the inratio device from the market. in view of this fda opinion and business considerations, alere recently decided to voluntarily remove the inratio system from the market.
  • Action
    Field Action Code mar / 16 triggered under the responsibility of the company Alere SA Company will collect for further destruction.

Device

Trade name: InRatio 2 Monitoring System Technical Name: Self-Test for Coagulation Parameters ANVI...

Manufacturer

Alere S.A.; 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
    ANVSANVISA