Events

Retiro De Equipo (Recall) de Xpert HIV-1 Viral Load 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 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-2016-RN-01272-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-10-07
  • 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-2016-RN-01272-1
  • 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
    Cepheid has received reports that some customers have experienced cartridge performance issues that manifest as abnormal pcr amplification curve patterns, which can yield invalid results (the most common outcome), or much less commonly, inaccurate quantification of hiv-1 rna when using this test and its intended use specimen types.
  • Acción
    Cepheid is advising users to stop using and dispose of any remaining product from the affected lot (Lot Number 1000034821). Replacement product will be provided. The results of previous tests performed with this lot of product should be discussed with the laboratory medical director to determine whether a look-back is required. If there are any concerns about the accuracy of the results contact Cepheid Technical Support who will analyse the GeneXpert data files (gxx files). This action has been closed-out on 10/05/2017.

Device

Xpert HIV-1 Viral Load Assay. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    Xpert HIV-1 Viral Load Assay. An in vitro diagnostic medical device (IVD).Catalogue Number: GXHIV-VL-CE-10 Lot Number: 1000034821 (Cartridge Lot: 14001)Expiration Date : 09 October 2016ARTG Number: 259967
  • Manufacturer
    Cepheid Holdings Pty Ltd

Manufacturer

Cepheid Holdings Pty Ltd