Events

Retiro De Equipo (Recall) de LifeCycle for Prenatal Screening software. 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 PerkinElmer.

¿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-2013-RN-00843-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-08-13
  • 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-2013-RN-00843-1
  • 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 become aware of an unexpected behaviour in how the lifecycle risk calculation engine (elipse) accepts and utilizes the ethnic factor given by the user. if the ethnic factor has been changed from a valid numeric value to "0" (zero) the case risk will not be calculated by applying the latest validated median equation as intended by the user.
  • Acción
    PerkinElmer is advising users to replace the default median equations supplied at installation with laboratory-specific ones and maintain the Marker Medians-form to ensure the Ethnic Factor values are greater than zero. PerkinElmer are recommending users update the software to version 4.0 rev 2. A review of past results should be made on a case by case bases as recommended by PerkinElmer.

Device

LifeCycle for Prenatal Screening software. An in vitro diagnostic medical device (IVD).
  • Modelo / Serial
    LifeCycle for Prenatal Screening software. An in vitro diagnostic medical device (IVD).Catalogue numbers: 5002-0020Software version: v2.1, v2.2, v3.0, v3.1, v3.2 (including all revisions)
  • Manufacturer
    PerkinElmer

Manufacturer

PerkinElmer