Events

Retiro De Equipo (Recall) de Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel 600i Synchron Access Clinical System. In vitro diagnostic medical devices (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-2012-RN-01160-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-11-21
  • 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-01160-1
  • 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 identified a potential problem in two pulley drive components in the mixer pulley assemblies of these systems.It has been determined that in some cases pulley drive components have broken parts or have become loose, mispositioned, or disconnected from their drive shafts. when these defects occur the pulley may not turn at all, or may turn at an incorrect speed, resulting in inadequate washing or mixing of the contents of the reaction vessel. beckman coulter is in the process of producing replacement components and will be installing them in every access/access 2 immunoassay, synchron lxi 725 clinical, and unicel dxc 6001 synchron access clinical system in the field.
  • Acción
    Beckman Coulter is providing work around instructions to mitigate the risk and replacing the mixer pulley assemblies to permanently fix the problem.

Device

Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel ...
  • Modelo / Serial
    Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel 600i Synchron Access Clinical System. In vitro diagnostic medical devices (IVD)
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd