Events

Retiro De Equipo (Recall) de BD BACTED FX - Top Unit and Bottom Unit (used to detect bacteria and fungi in clinical specimens)

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-01315-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-12-13
  • 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-01315-1
  • 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 some db bactec fx instruments contain racks that may demonstrate variable indicator light intensities. specifically, the anonymous vial indicator lights, which should appear yellow, may instead appear green in colour. this has the potential to lead a user of the instrument to accidentally discard an anonymous vial or the readings associated with an anonymous vial, before an anonymous vial has completed protocol. the affected instruments continue to function properly and will not report an incorrect result.
  • Acción
    BD is providing a software update to correct the issue, which will be available in February 2014. As an interim measure, BD is providing users with work around instructions to follow until the software upgrade is completed.

Device

BD BACTED FX - Top Unit and Bottom Unit (used to detect bacteria and fungi in clinical specimens)
  • Modelo / Serial
    BD BACTED FX - Top Unit and Bottom Unit (used to detect bacteria and fungi in clinical specimens)BD BACTED FX - Top UnitReference Number: 441385Serial Numbers: FT2899, FT2914, FT2951 & FT3077BD BACTEC FX - Bottom UnitReference Number: 441386Serial Numbers: FB1724 & FB1756
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd