Events

Retiro De Equipo (Recall) de BBL Crystal Enteric/Nonfermenter ID 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-2014-RN-00599-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-05-30
  • 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-2014-RN-00599-1
  • 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
    Bd has determined that the crystal inoculum fluid within the bbl crystal enteric/nonfermentor (e/nf) identification kits from the referenced lots are labelled with incorrect expiration dates. the crystal inoculum fluid bottles expire prior to the date that was printed on the kit carton. the expiration date printed on the individual crystal inoculum fluid bottles is correct.
  • Acción
    BD is requesting their customers to discard the outer boxes that are labelled with the incorrect expiration date.

Device

BBL Crystal Enteric/Nonfermenter ID Kit. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    BBL Crystal Enteric/Nonfermenter ID Kit. An in vitro diagnostic medical device (IVD).Catalogue Number: 245000Lot Numbers: 3224281 & 3290379ARTG Number: 195682
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd