Events

Retiro De Equipo (Recall) de Unicel DxH Slidemaker Stainer Coulter Cellular Analysis System. 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-2017-RN-00808-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-06-22
  • 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-2017-RN-00808-1
  • 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 determined that a fitting installed in a select population of slidemaker stainer (sms) units may not completely seal after being installed. please note that not all fittings installed may be affected. for those affected, one may observe a slow dripping leak of the staining reagents (methanol, alcohol and buffers) into the spill tray below designed for this purpose. there is no impact to patient results due to this issue. there is no new or additional safety risk associated with this issue beyond the continued potential of exposure to stain and methanol associated with the handling of these chemicals resulting from a slow dripping leak.
  • Acción
    Beckman Coulter is asking that customers: 1 - Immediately contact your Beckman Coulter representative to schedule a service visit in the event of a leak. Beckman Coulter Field Service Engineers will replace the fitting on the impacted instruments. 2 - Inspect the reagent supply drawer for spills; if necessary, clean up with absorbent materials such as paper towels, and dispose in accordance with your local regulations and laboratory procedures. 3 - Follow best laboratory practices when using the instrument, which includes the use of appropriate personal protective equipment (PPE) to protect the user from exposure.

Device

Unicel DxH Slidemaker Stainer Coulter Cellular Analysis System. An in vitro diagnostic medical de...
  • Modelo / Serial
    Unicel DxH Slidemaker Stainer Coulter Cellular Analysis System. An in vitro diagnostic medical device (IVD)Software version 3.2Part Number: PN 775222ARTG Number: 177999
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd