Events

Retiro De Equipo (Recall) de Novocastra Lyophilised Mouse Monoclonal Antibody CD10 Reagents. 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 Microsystems 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-2015-RN-00892-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-09-14
  • 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-2015-RN-00892-1
  • 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 novocastra lyophilised mouse monoclonal antibody cd10 reagent lots do 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, which may result in inadequate staining and lead to weak or false negative pathology results. this could potentially result in misclassification of a neoplasm and inappropriate management.
  • Acción
    Leica Biosystems is advising users to cease use and destroy any remaining stocks of affected product. A review of previously obtained results is recommended at the discretion of the laboratory director and physician. This action has been closed-out on 03/03/2017.

Device

Novocastra Lyophilised Mouse Monoclonal Antibody CD10 Reagents. An in vitro diagnostic medical de...

Manufacturer

Leica Microsystems Pty Ltd