Events

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

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-2015-RN-00999-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-10-13
  • 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-2015-RN-00999-1
  • 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 issue was caused by an unintended rounding of the median equation factors that led to inadequate number of significant digits (decimals) in the default median equation. the equation was originally introduced in lifecycle version v4.0 rev4. due to the issue, the inhibin a mom level of an unaffected population was observed to be approximately half from what it should have been. this unintended rounding error was observed internally and no customer complaints have been received.
  • Acción
    Perkin Elmer is providing users with instructions to correct the error. Alternatively, Perkin Elmer can implement the correction at the affected site. This action has been closed-out on 19/08/2016.

Device

LifeCycle for Prenatal Screening software
  • Modelo / Serial
    LifeCycle for Prenatal Screening softwareCatalogue Number: 5014-0020 Version Number: v4.0 Rev4ARTG Number: 216895
  • Manufacturer
    PerkinElmer

Manufacturer

PerkinElmer