Events

Retiro De Equipo (Recall) de UniCel DxI 800 Access Immunoassay Systems, Unicel DxI 600 Access Immunoassay Systems, UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical System. In vitro diagnostic medical devices (IVDs)

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-00107-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-02-06
  • 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-00107-1
  • 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
    Improper tubing installing by the customer during routine maintenance may prevent the dxi and dxc systems from washing reaction vessels properly and may lead to erroneous test results. the reason for the customer mis-routing of instrument tubing was determined to be two fold:- the mechanical controls on the instrument were insufficient to prevent incorrect routing of the aspirate and dispense tubing.- the instructional drawings in the service documentation were difficult for the customer to understand.This recall action was not notified to the tga before it was initiated by beckman coulter australia.
  • Acción
    Beckman Coulter Australia is advising that all affected systems were corrected with a new design that provided mechanical controls to reduce the potential for tubing installation errors. Also, updated service documentation with clearer instructions were distributed to affected customers.

Device

UniCel DxI 800 Access Immunoassay Systems, Unicel DxI 600 Access Immunoassay Systems, UniCel DxC ...
  • Modelo / Serial
    UniCel DxI 800 Access Immunoassay Systems, Unicel DxI 600 Access Immunoassay Systems, UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical System. In vitro diagnostic medical devices (IVDs)Part numbers: 973100, A30260, A71456, A71457, A71460, A71461, A25285, A25288, A92060
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd