Events

Retiro De Equipo (Recall) de Prosigna Breast Cancer Prognostic Gene Signature Assay. 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 Bio-Strategy 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-2017-RN-00563-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-05-08
  • 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-2017-RN-00563-1
  • 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
    The manufacturer nanostrong technologies has identified a quality issue with a single lot of the prosigna kit that may result in an error 35 of the prosigna assay due to high background. a specific failure mode has been observed at an elevated rate with prosigna kit lot 0100531017. this failure mode is pre-emptively identified by the embedded software, resulting in the output of an error by the system without the output of any test result. if this failure mode is experienced, a result for the sample would not have been obtained. if a test result was generated using this lot of kits, those results are not affected.
  • Acción
    Bio-Strategy is advising users to quarantine and place all unused kits from lot 0100531017 in a box at ambient temperature ready for collection. Bio-Strategy will arrange for the collection and replacement of unused kits.

Device

Prosigna Breast Cancer Prognostic Gene Signature Assay. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Prosigna Breast Cancer Prognostic Gene Signature Assay. An in vitro diagnostic medical device (IVD)Product Codes: NANPROSIGNA-002, NANPROSIGNA-003Lot Number: 0100531017ARTG Number: 226487
  • Manufacturer
    Bio-Strategy Pty Ltd

Manufacturer

Bio-Strategy Pty Ltd