Events

Retiro De Equipo (Recall) de 942-073, D8088_Crea A, D8089_Crea B Membranes used on the ABL827 blood gas 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 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-2014-RN-00994-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2014-09-15
  • 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-00994-1
  • 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 medical has become aware that lot r0530 of 942-073, d8088-crea a,d8089-crea b, membrane box for e8088 and e8089 electrodes has been packed in error with capsules of electrolyte solutions for glucose/lactate electrodes. testing by the manufacturer has established that the incorrect capsules of electrolyte solutions do not influence the performance of the crea results.
  • Acción
    Radiometer is requesting their customers to discard remaining units from the affected lots. Alternative units are available. This action has been closed-out on 01/03/2016.

Device

942-073, D8088_Crea A, D8089_Crea B Membranes used on the ABL827 blood gas analyser. An in vitro ...
  • Modelo / Serial
    942-073, D8088_Crea A, D8089_Crea B Membranes used on the ABL827 blood gas analyser. An in vitro diagnostic medical device (IVD)Lot Number: R0530
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd