Events

Retiro De Equipo (Recall) de Indiko and Indiko Plus Chemistry Analysers

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Thermo Fisher Scientific 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-2014-RN-00212-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-02-26
  • 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-2014-RN-00212-1
  • 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
    Internal investigations have revealed that cuvettes intermittently may be used twice, and as a consequence there is the potential for erroneous results to be generated without the operator being aware that this has occurred.
  • Acción
    Thermofisher is advising all end users to immediately stop using any analyser with software versions prior to 5.1.1. Thermo Fisher will provide their customers with a mandatory update to software version 5.1.1. Technical Support will be contacting customers as a matter of urgency to schedule the update.

Device

Indiko and Indiko Plus Chemistry Analysers

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd