Events

Notificaciones De Seguridad De Campo acerca de HITADO D-Dimer

Según Swiss Agency for Therapeutic Products, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Switzerland que fue producido por gabmed GmbH.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    Vk_20161024_07
  • Fecha de publicación del evento
    2016-10-31
  • País del evento
    Switzerland
  • Fuente del evento
    SATP
  • URL de la fuente del evento
    https://fsca.swissmedic.ch/mep/#?q=Vk_20161024_07
  • Notas / Alertas
    The data from Switzerland is current through March 2018. All of the data comes from Swiss Agency for Therapeutic Products, 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 recall data from the U.S. and Switzerland.
  • Notas adicionales en la data

Device

HITADO D-Dimer
  • Modelo / Serial
    HI-311-39651208 | see FSN
  • Descripción del producto
    IVD: D-Dimer - Rapid Test
  • Manufacturer
    gabmed GmbH

Manufacturer

gabmed GmbH
  • 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
    SATP