Events

Retiro De Equipo (Recall) de ARGENE Adenovirus R-gene and Parechovirus R- Gene Control Kits. (An in vitro diagnostic 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 Biomerieux 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-2018-RN-00143-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2018-02-20
  • 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-00143-1
  • 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
    It has been identified that a proportion of kits in the argene range have been mislabelled, where the target name is missing from the tube label. the kits are colour coded by reference to minimise the risk of mixing tubes from different references.
  • Acción
    BioMerieux is advising users that the affected product can continue to be used. Users are reminded that the affected products are colour coded by reference, and include the reference number on the labelling.

Device

ARGENE Adenovirus R-gene and Parechovirus R- Gene Control Kits. (An in vitro diagnostic medical d...
  • Modelo / Serial
    ARGENE Adenovirus R-gene and Parechovirus R- Gene Control Kits. (An in vitro diagnostic medical device)Adenovirus R-gene Quantification Standard (QS) and Sensitivity Control (SC)Refernece Number: 69-010BLot Number: 1005056960Expiry date: 25/08/2018Parechovirus R-gene Postive control (PC20)Reference Number: 71-020Lot Number: 1005090480Expiry Date: 31/08/2018ARTG Number: 211361 (Biomerieux Australia - Viral infectious disease IVDs)
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd