Events

Retiro De Equipo (Recall) de ABL90 FLEX Analyser. An in vitro diagnostic medical device (IVD) (blood gas analyser)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Radiometer Pacific 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-01128-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-11-06
  • 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-01128-1
  • 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
    Radiometer has recently become aware of a potential issue of negative bias on sodium results if the abl90 is not on a horizontal table. when tilted by 10 degrees or more and idle for 30 -45 minutes the magnitude of the effect on sodium results is as large as 10 mm (7%) in the worst case.
  • Acción
    Radiometer is advising users to ensure that the ABL90 is placed on a horizontal platform/table. If the analyser is on a roll stand users must ensure that the support plate is aligned horizontally and locked in position. Radiometer will perform alignment of roll stands on request. A detection mechanism will be provided in an upgraded version of the analyser software to eliminate the possibility of error.

Device

ABL90 FLEX Analyser. An in vitro diagnostic medical device (IVD) (blood gas analyser)
  • Modelo / Serial
    ABL90 FLEX Analyser. An in vitro diagnostic medical device (IVD) (blood gas analyser)
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd