Events

Retiro De Equipo (Recall) de Dengue NS1 Ag Strip

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Bio-Rad Laboratories 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-01238-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-12-22
  • 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-01238-1
  • 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
    There has been a sudden degradation of the sensitivity of certain lots of dengue ns1 ag strips, which has resulted in false negative results for positive patient samples.
  • Acción
    Bio-Rad is advising users to inspect stock (including units currently in use) and discard the affected units. Affected lots will be replaced. This action has been closed-out on 30/08/2016.

Device

Dengue NS1 Ag Strip
  • Modelo / Serial
    Dengue NS1 Ag StripCatalogue Number: 70700Serial/Lot Numbers:5F0130 Expiry Date: 30 March 20165H0131 Expiry Dates: 30 April 2016 and 15 May 20165H1131 Expiry Dates: 30 April 2016 and 15 May 20165H2131 Expiry Dates: 30 April 2016 and 15 May 2016ARTG Number: 207118An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd