Events

Retiro De Equipo (Recall) de AU2700/AU2700 Plus and AU5400 Clinical Chemistry Analysers, 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 Beckman Coulter 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-2013-RN-00402-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-05-07
  • 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-2013-RN-00402-1
  • 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
    Beckman coulter implemented a redesigned detergent tube, replacing the tubing with a more pliable material to allow for easier insertion to the detergent tank. new complaints that the joint connecting the tubing is disintegrating over time have been received. disintegration of the tubing/joint has the potential to result in detergent leaks.
  • Acción
    Beckman Coulter has requested their customers to implement work around maintenance procedures until a new tubing design can be implemented. Customers are also requested to discontinue use of the analyser and contact Beckman Coulter immediately if a leak occurs.

Device

AU2700/AU2700 Plus and AU5400 Clinical Chemistry Analysers, an in vitro diagnostic medical device...
  • Modelo / Serial
    AU2700/AU2700 Plus and AU5400 Clinical Chemistry Analysers, an in vitro diagnostic medical device (IVD)(Customers with modifications AU2700-184, AU5400-190 Complete)
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd