Events

Retiro De Equipo (Recall) de BD Phoenix Gram Negative Panels containing colistin. (An in vitro medical device)

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-2018-RN-00072-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-01-25
  • 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-2018-RN-00072-1
  • 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
    As a result of continuous surveillance on antimicrobial resistance, becton dickinson (bd) are aware of newly recognised or emerging strains that may yield an increased rate of false susceptibility in in vitro antimicrobial susceptibility test (ast) results to colistin.The labelling currently provided with the bd gram negative panels (nmic) panels indicates that colistin susceptibility can be determined. emerging strains have led to an increased number of resistant isolates reporting as susceptible when tested using the bd nmic panels with bd phoenix instrumentation.
  • Acción
    BD is advising users to perform an alternate method of testing prior to reporting susceptible colistin results. A resistant Phoenix colistin result does not require alternate testing. BD is not requesting that customers discard, return or discontinue use of the product. BD is also providing guidance for EpiCenter and BD Phoenix 100 &M50; instrument customers where rules can be created in the software to identify resistant isolates.

Device

BD Phoenix Gram Negative Panels containing colistin. (An in vitro medical device)
  • Modelo / Serial
    BD Phoenix Gram Negative Panels containing colistin. (An in vitro medical device)Catalogue Number: 448788 Lot Numbers: ALLARTG Number 197287 (Becton Dickinson Pty Ltd - Antimicrobial susceptibility testing IVDs)
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd