Retiro De Equipo (Recall) de LifeCycle for Prenatal Screening v4.0, v4.0 Rev 2 and v4.0 Rev 3. 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Wallac oy, a subsidiary of perkinelmer, has become aware that lifecycle for prenatal screening (5014-0020) may generate an incorrect risk calculation result for twins if lifecycle v4.0 risk calculation protocol is used and a particular sequence of actions occur.The issue is related to chorionicity correction of twins, which can be applied only with biomarker results for hcgb, papp-a and plgf in 1st trimester. if a second sample (e.G. 2nd trimester or dvpi examination) is attached to the same case, the moms should be cleared in order to recalculate the moms without chorionicity correction. if there are no gestational age calculation changes made, the 1st trimester sample moms will remain. since 1st trimester moms are chorionicity corrected when chorionicity is given, the mom values are too low resulting in unexpected risk values. if close to cut-off, a true risk value might end up on the opposite side of the cut-off and be reported as opposite risk result.
  • Acción
    Customers are advised that if they are using the affected software version and follow the sequence of actions that will result in the above issue, they should ensure that the MoM’s for hCGb, PAPP-A and PlGF biomarkers are always cleared before recalculating the risk when a second sample is added to the same case. This can be achieved by clearing the chorionicity information and saving the case data. PerkinElmer has developed a Database Investigation Script that can be used to determine if any affected calculations exists in customer’s LifeCycle database. Any decisions regarding the need to reassess/recalculate previously reported risk value results should be made on a case by case basis. Software v4.0 Rev 4 is under development and will correct this issue. Customers will be notified when the software update is available and it will be provided to them free of charge. This action has been closed-out on 11/08/2016.


  • Modelo / Serial
    LifeCycle for Prenatal Screening v4.0, v4.0 Rev 2 and v4.0 Rev 3. An in vitro diagnostic medical device (IVD)Catalogue number: 5014-0020ARTG Number: 216895
  • Manufacturer