Events

Retiro De Equipo (Recall) de B.R.A.H.M.S Free BhCG Kryptor 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 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-2016-RN-00223-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-03-01
  • 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-00223-1
  • 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 has confirmed that the affected lots observe an overestimation of approximately 10% of free bhcg concentration in diluted samples or controls. undiluted samples and controls are not affected by the issue.The dilution of samples may lead to incorrect risk estimation for foetal chromosomal abnormalities. a patient may be considered at higher risk for trisomy 21 or at lower risk for trisomy 13/18.
  • Acción
    ThermoFisher Scientific is advising users that the affected lot can continue to be used for undiluted samples only. The affected lot should be discarded once the replacement product has been provided. This action has been closed-out on 09/05/2017

Device

B.R.A.H.M.S Free BhCG Kryptor Kit. An in vitro diagnostic medical device (IVD)
  • Modelo / Serial
    B.R.A.H.M.S Free BhCG Kryptor Kit. An in vitro diagnostic medical device (IVD)Kit Reference Number: 809.075Lot Numbers: 09075 and 09073 ARTG Number: 199700
  • Manufacturer
    Thermo Fisher Scientific

Manufacturer

Thermo Fisher Scientific