Events

Retiro De Equipo (Recall) de FilmArray Blood Culture Identification (BCID) Panel when used with BD BACTEC Blood Culture Bottles. An in vitro diagnostic 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 Biomerieux Australia 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-00271-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-04-19
  • 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-2018-RN-00271-1
  • 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
    Biomérieux australia has been advised that the manufacturer, biofire diagnostics, has identified an increased risk of false positive proteus results when the filmarray blood culture identification (bcid) panel is used with bd bactec blood culture bottles with expiration dates of september 30, 2018 and october 31, 2018. it is unknown if subsequent lots of media will also be subject to this risk; however, biofire and bd are continuing to investigate the issue.
  • Acción
    bioMérieux is advising customers to verify positive results for Proteus by confirming with another method where BD BACTEC Blood Culture Bottles with expirations on 30/09/2018 and 31/10/2018 have been used due to the BCID Panel detecting nucleic acid from non-viable Proteus.

Device

FilmArray Blood Culture Identification (BCID) Panel when used with BD BACTEC Blood Culture Bottle...
  • Modelo / Serial
    FilmArray Blood Culture Identification (BCID) Panel when used with BD BACTEC Blood Culture Bottles. An in vitro diagnostic medical device. All lots of FilmArray Blood Culture Identification (BCID) Panel are impacted when used with specific BD media typesMultiple BD BACTEC Blood Culture Bottles with expiry dates of September 30 2018 and October 31 2018 may impact resultsARTG Number: 223979(Biomerieux Australia - Bacterial infectious disease IVDs)
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd