Events

Retiro De Equipo (Recall) de Unicel DxH 800, SMS and 600 systems, with software versions 3.0.2.0 and 1.1.1.0. 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-2015-RN-01204-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-12-09
  • 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-01204-1
  • 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
    During internal testing, it was determined that the software for various dxh systems allows for the creation of multiple orders with the same specimen identification (id), but a different patient identification when manually editing pending orders at the system manager.This issue does not occur for edits of released results or for test orders requested through host transmission.There is a possibility of sample misidentification and the release of erroneous results.
  • Acción
    Beckman Coulter is advising users not to edit the Specimen ID for a pending test order at the System Manager's Worklist. A software upgrade will be available to correct the issue. This action has been closed out on 13 Jun 2017.

Device

Unicel DxH 800, SMS and 600 systems, with software versions 3.0.2.0 and 1.1.1.0. An in vitro diag...
  • Modelo / Serial
    Unicel DxH 800, SMS and 600 systems, with software versions 3.0.2.0 and 1.1.1.0. An in vitro diagnostic medical device (IVD)Unicel DxH 800 Coulter Cellular Analysis SystemReference Numbers: 629029, B24465 and B24802Software version: 3.0.2.0Unicel DxH SMS Coulter Cellular Analysis SystemReference Numbers: 775222Software version: 3.0.2.0Unicel DxH 600 Coulter Cellular Analysis SystemReference Numbers: B23858Software version: 1.1.1.0ARTG Number: 177999
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd