Events

Retiro De Equipo (Recall) de Radiometer pCO2 membrane (D788) for ABL7/8xx analyzers

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Radiometer Medical ApS.

¿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
    15014
  • Fecha de inicio del evento
    2016-11-29
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Radiometer Pacific, Unit 3, 33 Spartan Road, Takanini 2105
  • Causa
    Possible negative bias on pco2 result on both blood and qc after membrane replacement. this bias can be seen after the replacement of the membrane., update: the temporary countermeasures, regarding the additional requirement for manually narrowing the qc ranges for pco2 and also performing extra qc measurements as communicated in july 2013 are no longer required and may be revoked upon installation of the improved sealing ring on the ph electrodes in abl700 and abl800 series analyzers., 01-02-2017: this notification is to inform you that your radiometer representative has now installed the improved sealing ring for the ph electrode in your abl700 and/or abl800 series analysers.
  • Acción
    Manufacturer to issue advice regarding use

Device

Radiometer pCO2 membrane (D788) for ABL7/8xx analyzers

Manufacturer

Radiometer Medical ApS