Events

Retiro De Equipo (Recall) de Novocastra Liquid Mouse Monoclonal Antibody Calretinin. 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-2016-RN-00563-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-04-29
  • 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-2016-RN-00563-1
  • 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
    In the event that the product is used with diluents other than those listed, it may not provide adequate staining. when used according to the instructions for use with appropriate positive controls, the failure to adequately stain would be apparent to the user on the control tissue and on the patient tissue. in these instances, the absence of adequate staining of tissue is likely to result in a delay in obtaining the results of ihc / ish staining and, in a worst-case scenario, could cause a delay in the diagnosis or classification of a neoplasm.
  • Acción
    Leica is advising users to only use Novocastra Liquid Mouse Monoclonal Antibody Calretinin with the specified diluents. There is no need for retrospective review of tissue staining if appropriate positive controls were properly used and interpreted during the immuno / in situ staining. This action has been closed-out on 25/01/2017.

Device

Novocastra Liquid Mouse Monoclonal Antibody Calretinin. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Novocastra Liquid Mouse Monoclonal Antibody Calretinin. An in vitro diagnostic medical device (IVD)Product Code: 1ml NCL-L-CALRET-566Lot Numbers: 6025204, 6029060, 6036060Only to be used in combination with:Diluent Lot NumbersAR9352 SLBL4196V, SLBL8154V, SLBM1997V, SLBM3199VAR9352-CN SLBL8154V SLBM1997VRE7133-CE 6035000RE7133-CN 6035115ARTG Number: 178442
  • Manufacturer
    Leica Microsystems Pty Ltd

Manufacturer

Leica Microsystems Pty Ltd