Notificaciones De Seguridad De Campo acerca de Alere Determine HIV-1/2 Ag/Ab Combo

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 Alere.

¿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
  • País del evento
  • Fuente del evento
  • 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
    This action is being initiated as a result of alere’s post market surveillance activity. specifically, negative results were obtained from a single sample in the eqa ring trial in europe. this sample was taken from a 40 year old man with a 7 day history of fever, rash and fatigue and contained p24 antigen of a virus of subtype c at a concentration of 250 pg / ml (viral load of 2,500,000 copies / ml), corresponding to 50 iu / ml (who standard). a recent publication of a survey conducted in swaziland also suggested that the antigen component of the alere determine hiv-1/2 ag/ab combo test in a high-prevalence, high-incidence setting was unable to detect acute infection in this subtype c population (yen t. duong et al., j. clin. microbiol. 2014, 52(10):3743-3748). .


  • Modelo / Serial
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • 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