Events

Retiro De Equipo (Recall) de Freelite Human Lambda Free kit for use on SPAPLUS

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-01425-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-11-09
  • 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-01425-1
  • 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 advised that investigations of the products have identified a change in the calibration curve shape that has occurred since product release. increased activity in the calibration curve between calibrators 5 and 6 has been observed and they have received reports of increased false prozone flags which is consistent with this issue.
  • Acción
    Customers are advised to immediately quarantine and dispose of any affected lots held by the customers and also to remove any affected lots from the SPAPLUS instrument. It is also advised to discuss the issues with the Medical Director to identify any further actions are required including reviewing the previously reported results.

Device

Freelite Human Lambda Free kit for use on SPAPLUS
  • Modelo / Serial
    Freelite Human Lambda Free kit for use on SPAPLUSItem Numbers: TBSLK018S, TBSLK01810SLot Numbers: 400012, 400257Expiry: Nov 2017
  • Manufacturer
    In Vitro Technologies Pty Ltd

Manufacturer

In Vitro Technologies Pty Ltd