Events

Retiro De Equipo (Recall) de BD Vacutainer Heparin Tube. n 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 Becton Dickinson 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-01249-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-12-21
  • 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-01249-1
  • 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
    It has been reported that some tubes may contain an incorrect additive, potassium oxalate, instead of lithium heparin.The presence of potassium could result in falsely elevated potassium results and erroneous results for other analytes, which could lead to the misdiagnosis of serious illnesses.
  • Acción
    BD is advising users to immediately discontinue the use of the affected units and quarantine any remaining affected stock and return for credit. This action has been closed-out on 02/05/2017.

Device

BD Vacutainer Heparin Tube. n in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    BD Vacutainer Heparin Tube. n in vitro diagnostic medical device (IVD)Catalogue Number: 367885Lot Number: 5084266ARTG Number: 176053
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd