Events

Retiro De Equipo (Recall) de LIAISON Biotrin Parvovirus B19 IgM

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-2014-RN-00879-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-08-11
  • 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-00879-1
  • 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 when used on liaison xl analyzer.
  • Acción
    DiaSorin is recommending the retesting of all specimens resulting in an initial positive on the LIAISON XL analyzer unless, as part of the laboratory policy, these samples have already been confirmed by other method or by clinical evidence. The affected lots can still be used, but confirming all initially positive results with a different method or analyzer. DiaSorin is offering Parvovirus B19 IgM EIA, code V619IM free of charge to perform the retesting. This action has been closed-out on 03/06/2016.

Device

LIAISON Biotrin Parvovirus B19 IgM
  • Modelo / Serial
    LIAISON Biotrin Parvovirus B19 IgMPart Number: 317010Lot Number: 129022X, 129022X/1Expiry Date: 12 December, 2014ARTG Number: 203754An in vitro diagnostic medical device (IVD)
  • Manufacturer
    DiaSorin Australia Pty Ltd

Manufacturer

DiaSorin Australia Pty Ltd