Events

Retiro De Equipo (Recall) de cobas Product System Manager (PSM) (Analyser software), all versions. 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 Roche Diagnostics Australia Pty Limited.

¿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-01256-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-12-19
  • 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-01256-1
  • 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
    Psm can be configured to block the validation of patient results in the event of a qc failure. this mechanism may not function as expected if the analyser system time is ahead of the psm system time by more than 2 minutes.
  • Acción
    As an interim measure, the sponsor is providing work around instructions to reduce the probability of occurrence. A software update will be installed to permanently correct the issue as soon as possible.

Device

cobas Product System Manager (PSM) (Analyser software), all versions. An in vitro diagnostic medi...

Manufacturer

Roche Diagnostics Australia Pty Limited