Events

Retiro De Equipo (Recall) de BD Affirm VPIII Microbial Identification Tests (used for the testing of multiple infectious organisms). 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-2015-RN-00844-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-09-01
  • 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-00844-1
  • 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
    A portion of tests associated with the referenced lots/batches may exhibit blue speckles or fibres on the beads and cards. this issue would cause difficulty in interpreting test (control & patient) results across all beads. this would result in an invalid test.
  • Acción
    BD is advising users to discontinue use and discard any remaining stock. This action has been closed-out on 17/08/2016.

Device

BD Affirm VPIII Microbial Identification Tests (used for the testing of multiple infectious organ...
  • Modelo / Serial
    BD Affirm VPIII Microbial Identification Tests (used for the testing of multiple infectious organisms). An in vitro diagnostic medical device (IVD)Catalogue Number: 446252Lot/Batch Numbers: 5135673, 5138774Expiry Date: 09/02/2016ARTG Number: 223745
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd