Events

Retiro De Equipo (Recall) de Bulk Loader Module for cobas p 471 centrifuge unit(Automated clinical analytical systems designed to analyse biological samples for in vitro diagnostic purposes)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Roche Diagnostics Australia Pty Limited.

¿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-00923-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-09-15
  • 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-00923-1
  • 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
    Roche has received a complaint that one sample tube was opened inadvertently in a bulk loader module (blm) during the internal system transport. the opened sample tube fell down into the funnel and the sample material was spilled, contaminating the system and other samples on their outer surface. sample material could not be used to carry out the analysis.
  • Acción
    To prevent the above malfunction, a hardware modification kit has been developed and will be released by the end of September 2015, with subsequent installation by a Roche field service engineer. Until the modification kit is installed Roche is requesting that if the issue occurs end users must carryout a complete instrument clean according to the Bulk Loader Module (BLM) operator manual. This action has been closed-out on 29/08/2016.

Device

Bulk Loader Module for cobas p 471 centrifuge unit(Automated clinical analytical systems designed...
  • Modelo / Serial
    Bulk Loader Module for cobas p 471 centrifuge unit(Automated clinical analytical systems designed to analyse biological samples for in vitro diagnostic purposes)Part Number: 07084285001All Lot NumbersAll Software versionsARTG Number: 212706
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited