Events

Retiro De Equipo (Recall) de LifeCycle for Prenatal Screening, software versions V3.0, v3.1, v3.2, v4.0. 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-00125-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-02-13
  • 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-2013-RN-00125-1
  • 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 that lifecycle for prenatal screening may generate an incorrect risk calculation with ivf (in vitro fertilisation) screening cases. the problem occurs if the user enters data incorrectly in combination with a specific series of events as described below:· the user initially enters the mother’s birth date (dob) incorrectly for an ivf case, and calculates the risk using the incorrect dob· the user recognises the dob entry error, corrects the error by entering the correct dob and recalculates the risk · lifecycle does not utilise the corrected dob, and recalculates the risk using the initial, incorrect dob · lifecycle generates an incorrect risk calculation for the ivf screening case.
  • Acción
    The LifeCycle issue can be corrected by either upgrading to LifeCycle software version v4.0 Rev2, or by implementing dedicated software Service Pack (LifeCycle Service Pack 12-03c) to resolve the problem. End users are recommended to choose one of the two options and the software upgrade will be provided free of charge.

Device

LifeCycle for Prenatal Screening, software versions V3.0, v3.1, v3.2, v4.0. An in vitro diagnosti...
  • Modelo / Serial
    LifeCycle for Prenatal Screening, software versions V3.0, v3.1, v3.2, v4.0. An in vitro diagnostic medical device (IVD)Catalogue Numbers: 5002-0020, 5014-0020
  • Manufacturer
    PerkinElmer

Manufacturer

PerkinElmer