Events

Retiro De Equipo (Recall) de Alegria Anti-Intrinsic Factor Assay

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Immuno 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-00546-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-07-21
  • 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-00546-1
  • 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
    Analysis in quality control has identified and confirmed that the lots listed above of our alegria test org 247, anti-intrinsic factor, exhibit an overall lower level of optical density values. this effect bears the risk that some positive sample-values will fall below the cut-off and will falsely be read as negative.
  • Acción
    Immuno requested thier customers to destroy any remaining product from the affecetd lots. Due to the risk of false negative results Immuno recommended that negative samples where clinical symptoms of pernicious anaenia should be retested. This action has been closed-out on 18/02/2016.

Device

Alegria Anti-Intrinsic Factor Assay
  • Modelo / Serial
    Alegria Anti-Intrinsic Factor AssayProduct Code: ORG 247-24Lot Numbers: 24732425, 24732427 & 24733840
  • Manufacturer
    Immuno Pty Ltd

Manufacturer

Immuno Pty Ltd
  • Source
    DHTGA