Events

Retiro De Equipo (Recall) de Xpert MRSA/SA Blood Culture 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-01487-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-11-21
  • 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-2016-RN-01487-1
  • 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 a higher number of invalid results than would typically be expected when using this test and its intended use specimen types. as in all xpert assays, when the test is determined to be invalid due to a failure of a cartridge or instrument quality check, no patient results are reported and the report designation is “invalid.”.
  • Acción
    Cepheid is advising customers to stop using the affected lot and dispose of any remaining product of this lot in their inventory. Cepheid will provide replacement product. This action has been closed-out on 18/05/2017.

Device

Xpert MRSA/SA Blood Culture Assay. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    Xpert MRSA/SA Blood Culture Assay. An in vitro diagnostic medical device (IVD).Catalogue Number: GXMRSA/SA-BC-CE-10Lot Number: 1000025828 (cartridge lot 12803)Expiry date: 2 April 2017ARTG Number: 242177
  • Manufacturer
    Cepheid Holdings Pty Ltd

Manufacturer

Cepheid Holdings Pty Ltd