Events

Notificaciones De Seguridad De Campo acerca de gabControl D-Dimer rapid test

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia 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
  • Fecha
    2016-10-18
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
  • Causa
    Due to weakly visible test lines in the said batches, it came to an increased amount of false-negative results. although the potential risk is considered to be minor with a test considered to be a pre diagnostic test, the product is being recalled from the european market by the gabmed gmbh as a precautionary measure to prevent false negative results. as the test is used as an aid in diagnosis, there is residual risk that additional .

Device

gabControl D-Dimer rapid test
  • Modelo / Serial
    M09DD02 D-Dimer rapid test DIM16070008 04-2018 M09DD02 D-Dimer rapid test DIM16070007 04-2018 M09DD02 D-Dimer rapid test DIM16050005 04-2018 M09DD02 D-Dimer rapid test DIM16050004 04-2018 M09DD02 D-Dimer rapid test DIM16030006 03-2018 M09DD02 D-Dimer rapid test DIM16030001 02-2018 M09DD02 D-Dimer rapid test DIM16020004 12-2017 M09DD02 D-Dimer rapid test DIM16010006 12-2017 M09DD02 D-Dimer rapid test DIM16010003 11-2017 M09DD02 D-Dimer rapid test DIM16010002 12-2017 M09DD02 D-Dimer rapid test DIM15120003 11-2017 M09DD02 D-Dimer rapid test DIM15100003 10-2017 M09DD02 D-Dimer rapid test DIM15050008 05-2017 M09DD02 D-Dimer rapid test DIM15050007 05-2017 M09DD02 D-Dimer rapid test DIM15050006 05-2017 M09DD02 D-Dimer rapid test DDI150303 03-2017 M09DD02 D-Dimer rapid test DDI150302 03-2017 M09DD02 D-Dimer rapid test DDI141202 12-2016 M09DD02 D-Dimer rapid test DIM15060002 05-2017 M09DD02 D-Dimer rapid test DIM15060001 05-2017
  • 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
    AMPMDRS