Retiro De Equipo (Recall) de Radiometer ABL90FLEX and ABL90FLEX PLUS Blood Gas Analyser with software version below 3.2. 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 risk that the analyser may report patient results although the analyser performance has not been verified by running quality controls. ultimately, this could lead to incorrect results being reported and these results will not be flagged. in a case where the patient has abnormal values for a parameter(s), the patient may erroneously be perceived as having normal values. this may lead to wrongful diagnosis and wrongful treatment. in a worst-case scenario, the patient may be subjected to lack of critical treatment.The issue may occur if the operator manually exits the conditioning mode, which is active during the initial start-up of a new sensor cassette. if “exit conditioning” is pressed to run an urgent sample the analyser goes to “ready” with- out performing three levels of quality control, which are run upon automatic exit.The regular qc schedule, one level every eight hours, will be effective though.
  • Acción
    Radiometer is providing users with work around instructions as an interim measure. Users are advised to avoid exiting the Conditioning Mode manually, or if an early exit is required, to manually re-run the three levels of QC before running any patient samples. Radiometer is investigating the issue and will provide an update to inform users about the long term solution which will be put in place to prevent the above situation from occurring. The long term solution is expected to be an update of the analyser software and of the Instructions for Use.


  • Modelo / Serial
    Radiometer ABL90FLEX and ABL90FLEX PLUS Blood Gas Analyser with software version below 3.2. An in vitro diagnostic medical device (IVD)ARTG Number: 228382
  • Manufacturer