Events

Retiro De Equipo (Recall) de Liaison Biotrin Parvovirus B19 IgM (testing kit), An in vitro diagnostic medical device (IVD)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por DiaSorin 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-2012-RN-01286-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-12-19
  • 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-2012-RN-01286-1
  • 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
    Diasorin has become aware that the kit lots identified have a potential to produce an increased rate of positive results.
  • Acción
    DiaSorin is asking users to retest all initially reactive specimens unless these samples have already been confirmed by another method. Affected lots may still be used to confirm results that are initially reactive by a different method.

Device

Liaison Biotrin Parvovirus B19 IgM (testing kit), An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Liaison Biotrin Parvovirus B19 IgM (testing kit), An in vitro diagnostic medical device (IVD)Catalogue number: 317010Batch / serial number: 129014X, 129014X/1Expiration Date: 7 April 2013Batch / serial number: 129015X, 129015X/1Expiration Date: 28 May 2013
  • Manufacturer
    DiaSorin Australia Pty Ltd

Manufacturer

DiaSorin Australia Pty Ltd