Events

Retiro De Equipo (Recall) de Access 2 Immunoassay System with Software Version 3.4. 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-00469-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-05-17
  • 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-00469-1
  • 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 confirmed that access 2 software version 3.4 has the potential to cause communication errors between the instrument and the console computer that are not recognised by the access 2 system. if this communication error occurs, the system will halt any samples that are in-process and test results will not be imported. the clearing of the communication error cannot be resolved by the customer and the instrument will be inoperable until a service engineer performs a system restore.
  • Acción
    If this communication error does occur, immediately contact the Beckman Coulter representative who will perform the necessary procedures to restore the affected system. A Beckman Coulter representative will restore all Access 2 systems to the previous unaffected software version.

Device

Access 2 Immunoassay System with Software Version 3.4. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Access 2 Immunoassay System with Software Version 3.4. An in vitro diagnostic medical device (IVD)Affected serial numbers: 504105 and 800084
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd