Events

Retiro De Equipo (Recall) de UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System

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-2016-RN-01049-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-08-09
  • 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-2016-RN-01049-1
  • 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 received and confirmed a report of a fire within the stainer module of a customer’s dxh slidemaker stainer. the fire was fully contained within the stainer module. the event was preceded by a significant increase in the frequency of the automatic top-off of the module’s methanol bath. users are being advised to discontinue use of the stainer module to reduce the potential for flammable liquids coming into contact with electrical components in the stainer module possibly causing a fire. beckman coulter is actively investigating the reported incident to determine the root cause, and define and implement required corrective and preventive actions.
  • Acción
    Beckman Coulter is advising users to: 1. Immediately discontinue use of the Stainer module. 2. Drain all liquids from the Stainer module. 3. Follow the directions provided for placing the Stainer module in extended shutdown and disabling the Stainer. Once the Stainer has been disabled, the Slidemaker module may be used to prepare slides for staining. Slides must be stained using an alternative method. A Beckman Coulter service representative will schedule a visit to modify the Stainer module so that it remains disabled and cannot be used until further corrective action is implemented. This action has been closed-out on 02/03/2017.

Device

UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System

Manufacturer

Beckman Coulter Australia Pty Ltd