Events

Retiro De Equipo (Recall) de Lactate membrane for ABL700 series and ABL800 series blood gas analysers (Part 942-066, D7077) . 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 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-2012-RN-01108-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-11-01
  • 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-2012-RN-01108-1
  • 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
    Potential enzyme residue on the outside of a newly replaced lactate membrane may cause an initial negative bias on the reported lactate result. if this residue exists the bias will decrease over the in-use time.
  • Acción
    Radiometer is providing work around instructions to mitigate the issue and are currently reviewing the manufacturing process to implement changes that will prevent the possibility of this occurrence

Device

Lactate membrane for ABL700 series and ABL800 series blood gas analysers (Part 942-066, D7077) . ...
  • Modelo / Serial
    Lactate membrane for ABL700 series and ABL800 series blood gas analysers (Part 942-066, D7077) . An in vitro diagnostic medical device (IVD)All lot numbers affected
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd