Events

Retiro De Equipo (Recall) de NCL-L-CD15. An in vitro diagnostic medical device (IVD).(NovocastraT Liquid Mouse Monoclonal Antibody)

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-01357-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-12-23
  • 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-01357-1
  • 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. no customer complaints relating to this issue have been received. there is the potential risk of a patient being diagnosed with incorrect tumor based on a false negative cd15 staining result. delay in diagnosis/ misdiagnosis of a patient with hodgkin’s disease. positive control tissue would show weaker than expected or negative staining. an unexpected result would be highlighted by the use of appropriate controls. additionally, if a pathologist did not follow standard medical practice there could be a possibility that an incorrect or delayed diagnosis could result and appropriate treatment for the patient could be delayed. this could possibly result in improper staging of the patient’s disease or resulting in the patient’s death.
  • Acción
    End users are requested to discard any remaining product from the affected lot and contact their Leica representative immediately if a replacement is required.

Device

NCL-L-CD15. An in vitro diagnostic medical device (IVD).(NovocastraT Liquid Mouse Monoclonal Anti...

Manufacturer

Leica Biosystems Melbourne Pty Ltd