Events

Retiro De Equipo (Recall) de BBL MGIT Mycobacteria Growth Indicator Tube(used for the detection and recovery of mycobacteria including mycobacterium tuberculosis)

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-00975-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-09-17
  • 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-00975-1
  • 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 affected bbl mgit tubes were labelled with an incorrect barcode, such that the correct barcode prefix "43 01" was actually printed as "43 02". the manufacturer identified this error prior to supplying the product and over labelled the product with the correct barcode. the manufacturer has identified that the over labels may peel off in varying degrees which exposes the incorrect barcode. this can result in mgit false negative results.
  • Acción
    BD is requesting users to discontinue use and discard any remaining inventory of the affected product. Replacement stock will be provided by BD. The package insert recommends that users perform a visual check of all instrument negative tubes. Tubes that appear to be positive should be sub-cultured, acid-fast stained and treated as a presumptive positive. A review of previously reported results is not required if this protocol is followed.

Device

BBL MGIT Mycobacteria Growth Indicator Tube(used for the detection and recovery of mycobacteria i...
  • Modelo / Serial
    BBL MGIT Mycobacteria Growth Indicator Tube(used for the detection and recovery of mycobacteria including mycobacterium tuberculosis)Catalogue Number: 245122Lot Number: 3061013Expiry date: 6 September 2014An in vitro diagnostic medical device (IVD)
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd