Events

Retiro De Equipo (Recall) de Xpert HIV-l Viral LoadAn in vitro 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 Cepheid Holdings 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-00012-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2018-01-12
  • 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-00012-1
  • 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
    Since beginning of 2017, three incidents of discrepant results were reported to the european competent authorities involving the xpert hiv-l viral load test and other alternative methods where the xpert hiv-1 viral load assay did not detect the variant of hiv.
  • Acción
    Cepheid recommends that each user of the Xpert HIV-l Viral Load test is informed about the update of the package insert which is now including the following additional limitation: “Rare mutations within the target region of the HIV-1 VL assay may affect primer and/or probe binding resulting in under-quantitation of virus.”

Device

Xpert HIV-l Viral LoadAn in vitro medical device
  • Modelo / Serial
    Xpert HIV-l Viral LoadAn in vitro medical deviceCatalogue number - GXHIV-VL-CE-10ARTG Number 259967 (Cepheid Holdings Pty Ltd - Human immunodeficiency virus (HIV) IVDs)
  • Manufacturer
    Cepheid Holdings Pty Ltd

Manufacturer

Cepheid Holdings Pty Ltd