Events

Retiro De Equipo (Recall) de Freelite Human Kappa Free Kit (use on the Beckman AU (400, 480, 640, 680, 2700, 5400) Series). 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-01298-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-10-06
  • 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-01298-1
  • 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 was determined through the course of a post-release product investigation that the control values on an affected lot of the freelite human kappa free kit require a reassignment which is 21% lower than the value established during the manufacture of the product. with the currently assigned values, if the controls are out of range (±20% of the concentration stated), then results of the run should not be accepted, which may lead to a delay in reporting results.
  • Acción
    In Vitro Technologies are providing users with revised values for the quality controls, which are to be used for the remainder of the shelf life of the Freelite Human Kappa Free Kit. This action has been closed out on 14 June 2017.

Device

Freelite Human Kappa Free Kit (use on the Beckman AU (400, 480, 640, 680, 2700, 5400) Series). An...
  • Modelo / Serial
    Freelite Human Kappa Free Kit (use on the Beckman AU (400, 480, 640, 680, 2700, 5400) Series). An in vitro diagnostic medical device (IVD)Item Number: TBSLK016AULot Number: 358004ARTG Number: 202167
  • Manufacturer
    In Vitro Technologies Pty Ltd

Manufacturer

In Vitro Technologies Pty Ltd