Events

Retiro De Equipo (Recall) de Access BR Monitor. 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 Beckman Coulter 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-2017-RN-00500-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-04-21
  • 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-00500-1
  • 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
    Beckman coulter has been informed that a study completed by the french competent authority ansm showed diagnosed cancer patients in non-remission of their metastatic disease, may have results below the upper reference limit (url) of 31.3 u/ml as stated in the access br monitor instructions for use (ifu). the ansm’s preliminary study demonstrated that 10 out of 27 patients diagnosed with cancer in non-remission had a result below the access br monitor url. in this preliminary study, at the cutoff of 31.3 u/ml designated in the access br monitor ifu, the assay achieved a sensitivity of 63% and a specificity of 100% for patients in non-remission.As a result, beckman coulter is evaluating the access br monitor cutoff. the conclusions of this evaluation are planned to be available by the third quarter of 2017.
  • Acción
    Beckman Coulter is advising users that they are currently evaluating the Access BR Monitor cutoff. Users are reminded of the limitations of the assay which are included the current IFU and detailed in the customer letter. These relate to the intended use of the assay as an aid in the management of breast cancer patients and not as a screening tool, the interpretation of CA 15-3 antigen concentration results and the laboratory's establishment of reference ranges to assure proper representation of specific populations.

Device

Access BR Monitor. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Access BR Monitor. An in vitro diagnostic medical device (IVD)Reference Number: 387620All non-expired lots and future lotsARTG Number: 213975
  • Manufacturer
    Beckman Coulter Australia Pty Ltd

Manufacturer

Beckman Coulter Australia Pty Ltd