Events

Retiro De Equipo (Recall) de Small Form Factor Console PC (Used Access 2 Immunoassay System and the UniCel DxC 600i SYNCHRON Access Clinical 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 Beckman Coulter Australia 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-01087-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-10-10
  • 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-01087-1
  • 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
    Beckman coulter has determined that the access 2 console pc (b23083) may experience an “mfc exception” error during normal operation. if this error occurs, the system will exit the access 2 user interface (ui) screen and display a window that notifies the user of a “0==itubescancount” event. if the ui is re-launched, the system will prevent access to the sample manager screen to request samples for processing and the same “mfc exception” error will occur. the access 2 console pc ui error can cause a delay in reporting of results, but will not cause erroneous results.
  • Acción
    Beckman Coulter service representative will contact affected customers and schedule a service visit to modify their Console PC. In the interim, customers are advised to continue operating their systems normally and contact Beckman Coulter Customer Support Centre if the error occurs. This action has been closed-out on 20/04/2017.

Device

Small Form Factor Console PC (Used Access 2 Immunoassay System and the UniCel DxC 600i SYNCHRON A...
  • Modelo / Serial
    Small Form Factor Console PC (Used Access 2 Immunoassay System and the UniCel DxC 600i SYNCHRON Access Clinical System). An in vitro diagnostic medical device (IVD)Ref.: B23083 (small PC with silver faceplate)
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd