Events

Alerta De Seguridad O Notificaciones De Seguridad para Professional use HIV test

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom 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
    Safety alert / Field Safety Notice
  • Fecha
    2017-10-03
  • Fecha de publicación del evento
    2017-10-03
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/professional-use-hiv-test-alere-hiv-combo-risk-of-false-positive-results
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notas adicionales en la data
  • Causa
    Manufactured by alere – point-of-care tests for use only in professional clinical settings: specific lots are affected.
  • Acción
    Identify affected devices, which are listed in the manufacturer’s Field Safety Notice (FSN). Where affected devices have been used, ensure that initially reactive p24 antigen and/or antibody results that were obtained from EDTA whole blood samples are retested using another method. Ensure the results are evaluated in consideration of the overall clinical evaluation before a diagnosis is made. Ensure all relevant members of staff receive the manufacturer’s Field Safety Notice (FSN). and that they understand the problem and to check that the actions have been taken.

Device

Professional use HIV test
  • Modelo / Serial
  • Manufacturer
    Alere

Manufacturer

Alere
  • Dirección del fabricante
    Simon Richards Alere Ltd Pepper Road Hazel Grove Stockport Cheshire SK7 5BWTel: 07785 387 505simon.richards@alere.com
  • 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
    MHRA