Events

Retiro De Equipo (Recall) de UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems. 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-2013-RN-01021-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-10-01
  • 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-2013-RN-01021-1
  • 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
    An internal investigation indicates that specific lots of check valves used in several locations within the dxh 800 and dxh 600 systems may fail. a failure may result in an air or liquid leak at the vcs waste chamber or probe waste chamber.
  • Acción
    End users are advised that if they experience a "Vent/overflow chamber detected overflow" error message, the three samples prior to the error message must be reviewed. Physical contact with leaks should be avoided by continuing to use protective equipment. A service representative will contact each customer to schedule an on-site visit for check valve inspection of any affected valves.

Device

UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems. An in vitro diagnostic medic...
  • Modelo / Serial
    UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems. An in vitro diagnostic medical device (IVD)UniCel DxH 800 Coulter Cellular Analysis SystemProduct Number: 629029UniCel DxH 600 Coulter Cellular Analysis SystemProduct Number: B23858
  • Clasificación del producto
    Hematology and Pathology Devices
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd