Events

Retiro De Equipo (Recall) de D-10 Haemoglobin Testing System. 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 Bio-Rad Laboratories 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-00280-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-03-04
  • 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-00280-1
  • 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
    On a rare occasion, the d-10 software might generate an extra result by duplicating the result from the previous sample and the sample id/injection # from the next sample. the duplicate is readily detectable when sorting the daily summary by the injection # and reviewing for duplication of the same sample id number. such duplication could potentially lead to discrepant sample results, which should not be reported.
  • Acción
    Bio-Rad are providing users with work around instructions to follow as an interim measure. Bio-Rad will release a permanent solution when available. This action has been clsoed-out on 18/02/2016.

Device

D-10 Haemoglobin Testing System. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    D-10 Haemoglobin Testing System. An in vitro diagnostic medical device (IVD)Catalogue Number: 220-0220
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd