Events

Retiro De Equipo (Recall) de The Binding Site SPAPLuS analyser. 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 In Vitro Technologies 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-00150-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2014-02-11
  • 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-00150-1
  • 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 vitro technologies have been notified by the manufacturer that the “prog error (overflow) det comm” pop-up message has been recently reported on a number of the spaplus analysers with the ‘c’ suffix on the serial number. when the error occurs, analysis will stop and a full shutdown is required to restart testing. in addition to this, it causes results to be lost and the test will be required to be repeated.
  • Acción
    In Vitro Technologies are advising users that a build up of static is the cause of the issue. A grounding unit will be installed on all affected units to prevent the error from occurring.

Device

The Binding Site SPAPLuS analyser. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    The Binding Site SPAPLuS analyser. An in vitro diagnostic medical device (IVD)All serial numbers with ‘C’ suffix Catalogue number: TBSIE610ARTG Number: 201723
  • Manufacturer
    In Vitro Technologies Pty Ltd

Manufacturer

In Vitro Technologies Pty Ltd