Events

Retiro De Equipo (Recall) de Rack Trays used with cobas, Modular Analytics and Urisys instruments/systems. 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 Roche Diagnostics Australia Pty Limited.

¿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-01279-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-10-05
  • 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-01279-1
  • 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
    Roche is updating the cleaning procedure for rack trays that are used with various cobas, modular analytics and urisys instruments as a result of reports of injury caused by sharp edges on the rack trays during cleaning. cuts may occur when fingers come in contact with rack tray edges, especially if a quick wiping movement is made along the edges of the rack tray. the updated cleaning procedure contains instructions for safe handling of the parts to avoid the risk of injury.
  • Acción
    Roche is providing users with updated cleaning instructions for the rack trays. This information will be incorporated into future versions of the respective instrument Operator Manuals. This action has been closed-out on 17/05/2017.

Device

Rack Trays used with cobas, Modular Analytics and Urisys instruments/systems. An in vitro diagnos...
  • Modelo / Serial
    Rack Trays used with cobas, Modular Analytics and Urisys instruments/systems. An in vitro diagnostic medical device (IVD). Various Rack Trays and instruments affectedMultiple Material Numbers affectedARTG Numbers: 173887 & 212706
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited