Events

Alerta De Seguridad para 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

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Alere S.A.; Alere San Diego, Inc..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    2135
  • Fecha
    2016-09-21
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Product pickup. Attached communiqué
  • Causa
    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.
  • Acción
    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.
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “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