Events

Retiro De Equipo (Recall) de UniCel DxC ISE Reference reagent tubingUniCel DxC 600/800

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-00697-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-08-03
  • 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-00697-1
  • 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 identified a failure of the unicel dxc ise tubing (lines 11, 25 and 26) for ise reference reagent. the failure occurs due to the interaction between a new tubing plasticiser and the ise reference reagent. the supplier's change in plasticiser was due to a move to a phthalate-free tubing material based on new environmental regulations. as a result, a visible slow-forming non-microbial white material may appear inside the tubing. this may result in suppressed ise quality control and patient results due to reference drift errors and/or ise calibration failures and/or tubing lines 25 or 26 detaching due to obstruction of flow.
  • Acción
    Users are requested to immediately perform a visual inspection of ISE Reference reagent tubing 11, 25, and 26 for the white material and in cases where material is identified a workaround is provided. In the longer term, Beckman Coulter is qualifying new ISE tubing and laboratories will be notified when new tubing is available to be installed on instruments subject to this Recall. This action has been closed-out on 02/05/2017.

Device

UniCel DxC ISE Reference reagent tubingUniCel DxC 600/800

Manufacturer

Beckman Coulter Australia Pty Ltd