Events

Retiro De Equipo (Recall) de Alere Determine HIV-1/2 Ag/Ab Combo (an in vitro diagnostic medical device)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Inverness Medical Innovations Australia Pty Ltd T/A Alere.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2014-RN-01216-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-11-13
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01216-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 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.
  • Acción
    Alere is notifying hospitals of the following additional assay limitations: - The test is designed to provide an additional, rapid testing option for the detection of HIV infections. The sensitivity of the Alere Determine HIV-1/2 Ag/Ab Combo is not equivalent to 4th generation HIV ELISA, p24 EIA or PCR, which limits its ability to detect acute infections in comparison to those methods. - Where clinical presentation or other data would suggest an inconsistent result then the patient should be tested by PCR and/or retested for antibodies to HIV >21 days after the original testing. This action has been closed-out on 18/03/2016.

Device

Alere Determine HIV-1/2 Ag/Ab Combo (an in vitro diagnostic medical device)

Manufacturer

Inverness Medical Innovations Australia Pty Ltd T/A Alere
  • 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
    DHTGA