Events

Retiro De Equipo (Recall) de BD HLA-B27 Kit (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 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-2013-RN-00249-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-03-19
  • 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-2013-RN-00249-1
  • 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
    The hla-b27 fitc/cd3 pe reagent in the bd hla-b27 kits is contaminated with cd4 pe. this results in an apparent elevated cell population.
  • Acción
    Laboratories are requested to discard all remaining stock from the affected lot of HLA-B27 kit.If the affected lot has been used, laboratories are requested to review and examine all data files for possible incorrect CD3 staining due to the contamination with CD4. Unless confirmatory testing has already been conducted, positive samples should be tested using an alternative method.

Device

BD HLA-B27 Kit (An in vitro diagnostic medical device (IVD))
  • Modelo / Serial
    BD HLA-B27 Kit (An in vitro diagnostic medical device (IVD))Catalogue Number: 340183Unit: KitLot Number: 3029914ARTG Number: 192529
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd