Events

Retiro De Equipo (Recall) de illumigene Malaria Kit. 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 Bioline Aust 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-2017-RN-00921-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-08-08
  • 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-2017-RN-00921-1
  • 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
    The manufacturer meridian has discovered that the sample preparation apparatus iv is susceptible to evaporation over the shelf life, causing low volume of the liquid reagent. post-market studies indicate that this component may not be stable through to the labelled expiration date due to this evaporation. internal testing by meridian has confirmed that the use of a low volume sample preparation apparatus component will result in an invalid test result.At this time, there is no indication that valid test results are impacted, and previously reported patient results require no additional action.
  • Acción
    Meridian is requesting customers: 1. Identify existing inventory of Kit Lots 280925H009, 280925H010, 280925J011, 280925J013, and 280925J015; 2. Contact Bioline directly, as necessary, for replacement product; 3. Complete and return the supplied Customer Response Form to Bioline; and 4. Upon receipt of replacement product, segregate and destroy remaining inventory of Kit Lots 280925H009, 280925H010, 280925J011, 280925J013, and 280925J015. All kit components should be discarded in accordance with local regulations.

Device

illumigene Malaria Kit. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    illumigene Malaria Kit. An in vitro diagnostic medical device (IVD).Catalogue Number: 280925Kit Lot Numbers:280925H009 Expiry: 23 August 2017Component involved: 2824.005280925H010 Expiry: 23 August 2017Component involved: 2824.006280925J011Expiry: 24 July 2018Component involved: 2824.008280925J013Expiry: 24 July 2018Component involved: 2824.009280925J015Expiry: 19 June 2018Component involved: 2824.007ARTG Number: 277788
  • Manufacturer
    Bioline Aust Pty Ltd

Manufacturer

Bioline Aust Pty Ltd