Events

Retiro De Equipo (Recall) de UniCel DxI Immunoassay Systems(Includes the UniCel DxI 600 and UniCel DxI 800 Access Immunoassay Systems; and the UniCel DxC 660i,UniCel DxC 680i, UniCel DxC 860i, and UniCel DxC 880i Synchron Access Clinical Systems)An in vitro diagnostic 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-2015-RN-00490-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-06-12
  • 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-2015-RN-00490-1
  • 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 updated the instructions for use (ifu) to incude the recommended temperature restrictions to address the impact of room temperature changes on certain assays run on unicel dxi immunoassay systems. the new updated operation range temperatures are between 18ºc to 28ºc. an updated version of the ifu is available on the beckman coulter website ( http://www.Beckmancoulter.Com).
  • Acción
    Beckman Coulter is notifying their customers that the updated version of the UniCel DxI Immunoassay Systems IFU is available on the Beckman Coulter website ( http://www.beckmancoulter.com) This action has been closed-out on 20/04/2017.

Device

UniCel DxI Immunoassay Systems(Includes the UniCel DxI 600 and UniCel DxI 800 Access Immunoassay ...
  • Modelo / Serial
    UniCel DxI Immunoassay Systems(Includes the UniCel DxI 600 and UniCel DxI 800 Access Immunoassay Systems; and the UniCel DxC 660i,UniCel DxC 680i, UniCel DxC 860i, and UniCel DxC 880i Synchron Access Clinical Systems)An in vitro diagnostic device (IVD)All Serial NumbersAll software versions
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd