Events

Retiro De Equipo (Recall) de Calibrator BRAHMS Free beta-hCG KRYPTOR CAL. 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 Thermo Fisher Scientific.

¿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-2014-RN-00155-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-02-13
  • 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-2014-RN-00155-1
  • 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
    Thermo fisher scientific would like to inform that the use of calibrator brahms free beta-hcg kryptor cal may result in a decreased free beta-hcg concentration for brahms gm kryptor qc as well as for patient samples by approximately 4%. this may lead to incorrect risk estimation of chromosomal anomaly of the foetus.
  • Acción
    Thermo Fisher Scientific is advising users to stop use of the affected lot number. The affected lot will be replaces by a previous calibrator which may have a shorter expiry date. Thermo Fisher is recommending that results generated with the affected calibrator are re-evaluated in the context of other laboratory and clinical parameters and retest if required.

Device

Calibrator BRAHMS Free beta-hCG KRYPTOR CAL. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    Calibrator BRAHMS Free beta-hCG KRYPTOR CAL. An in vitro diagnostic medical device (IVD)Lot Number: 09045Expiry Date: 16 October 2014Kit Reference Number: CDB80991
  • Manufacturer
    Thermo Fisher Scientific

Manufacturer

Thermo Fisher Scientific