Events

Retiro De Equipo (Recall) de Freelite Human Kappa Integra 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 In Vitro Technologies 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-00231-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-03-04
  • 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-00231-1
  • 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 has determined that the affected calibrator and controls require a reassignment which is 16% lower than the value established during the manufacture of this product. in vitro technologies is advising users to recalibrate the affected lots with the new calibrator values provided. the assay bias of 16% would result in a minimal change to low values. however the difference would be proportionately greater at higher values.
  • Acción
    In Vitro Technologies is providing users with revised target and range values to be used with the affected kits. The Director of Chemical Pathology should be consulted to determine the need for a review of results previously reported using this kit

Device

Freelite Human Kappa Integra Kit. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Freelite Human Kappa Integra Kit. An in vitro diagnostic medical device (IVD)Item Numbers: TBSLK01610RI and TBSLK016ILot Numbers: 354992, 355769ARTG Number: 202167
  • Manufacturer
    In Vitro Technologies Pty Ltd

Manufacturer

In Vitro Technologies Pty Ltd