Events

Retiro De Equipo (Recall) de Parechovirus r-gene. 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 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-2015-RN-00579-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-06-29
  • 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-2015-RN-00579-1
  • 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
    An internal investigation identified a shift of the ct values of lnternal control (ic1 w0, internal control with water) inside and outside the limit of specifications. the investigations performed by r&d; with ref. 71-020 lot 1002978600 showed that ct values results on the extraction control (ic1w0) with ct value close to the specification of validity (32 ct) or just above this specification. the ct shift values may be observed on a positive sample without impacting the limit of detection.
  • Acción
    Biomerieux is requesting their customers to discontinue using and discard any remaining inventory of the Parechovirus r-gene ref. 71-020 (WW) lot 1002978600. This action has been closed-out on 17/08/2016.

Device

Parechovirus r-gene. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Parechovirus r-gene. An in vitro diagnostic medical device (IVD)Catalogue Number: 71-020Serial Number: 1002978600Supplied as Research Use OnlyARTG Number: 211361
  • Manufacturer
    Biomerieux Australia Pty Ltd

Manufacturer

Biomerieux Australia Pty Ltd