Events

Retiro De Equipo (Recall) de Novocastra Liquid Mouse Monoclonal Antibody. 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 Leica Biosystems Melbourne 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-00028-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-01-16
  • 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-00028-1
  • 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
    Leica biosystems recently became aware that the product listed above does not function as intended up to the expiry date on the product labelling. there is a link between the age of the product and staining intensity. there is a remote risk of a patient being diagnosed with incorrect tumour based on a false negative cd15 staining result.
  • Acción
    Leica Biosystems is advising users to destroy any remaining unused stock. Leica Biosystems is advising users that clinical interpretation of staining or its absence should be evaluated within the context of the patient's clinical history. If this is not the case, clinicians may wish to review results obtained with the affected lot.

Device

Novocastra Liquid Mouse Monoclonal Antibody. An in vitro diagnostic medical device (IVD)

Manufacturer

Leica Biosystems Melbourne Pty Ltd