Events

Retiro De Equipo (Recall) de Coverstainer Slide Rack (automated staining instrument). 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 Dako Australia 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-2012-RN-01198-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-12-03
  • 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-2012-RN-01198-1
  • 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
    Based on an investigation it has been concluded that the expected lifetime of the coverstainer racks does not meet the set requirements. the consequence can be that slides are falling out of the rack during the staining process. slides falling out of the rack during the staining process would require a new slide preparation and staining process to be initiated. in the rare event, the patient may need to be called in for a new sample to be taken.This recall action was not notified to the tga before it was initiated by dako australia.
  • Acción
    Dako Australia Pty Ltd has advised their customer to discontinue use and return the Coverstainer Slide Racks for replacement.

Device

Coverstainer Slide Rack (automated staining instrument). An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Coverstainer Slide Rack (automated staining instrument). An in vitro diagnostic medical device (IVD)Model number: CS10330ARTG: 181957
  • Manufacturer
    Dako Australia Pty Ltd

Manufacturer

Dako Australia Pty Ltd