Events

Retiro De Equipo (Recall) de QConnect HBVNAT Positive

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Thermo Fisher Scientific Australia Pty Ltd.

¿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-2015-RN-01050-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-11-05
  • 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-2015-RN-01050-1
  • 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
    Certain lot numbers of the qconnect hbvnat positive control may give no results due to ic (internal control) failure when run on the abbott m2000.The affected lot numbers should not be run on the abbott m2000.To ensure all affected lots have been destroyed the respective product specialist for each area will visit each site to confirm there is no stock still in possession.
  • Acción
    Users are asked to quarantine all affected units from use prior to destruction. To ensure all affected lots have been destroyed the respective Product Specialist for each area will visit each site to confirm there is no stock still in possession. This action has been closed-out on 22/08/2016.

Device

QConnect HBVNAT Positive

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd