Events

Retiro De Equipo (Recall) de DELFIA Xpress PlGF Kit

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-00629-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-07-14
  • 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-00629-1
  • 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
    Perkin elmer has become aware that the stability of the plgf calibrators lot 637341 is impaired. the stability issue is limited to one lot of plgf calibrators. due to the impaired stability a decreasing trend in the signal level measured for the plgf calibrators occurs; the signal level of the plgf calibrators lot 637341 has decreased an average of 20% since release. the signal decrease results in the measured plgf concentrations for the qc controls and patient samples will be falsely high, expected increase is approximately +20%. perkin elmer investigations have identified the impaired stability of the plgf calibrators is due to an issue in the quality of a single batch of the raw material used in the manufacture of the plgf calibrators.
  • Acción
    Perkin Elmer is requesting the customers to check their inventory, immediately discontinue use and destroy all the affected DELFIA Xpress PlGF kit lots. PerkinElmer will replace all DELFIA Xpress PlGF Kits of the designated lots in the inventory. Perkin Elmer is further requesting the customers to review and repeat patient samples, if PlGF control values for completed DELFIA Xpress PlGF runs with the affected product lots are not within the established acceptance range. This action has been closed-out on 04/05/2017.

Device

DELFIA Xpress PlGF Kit
  • Modelo / Serial
    DELFIA Xpress PlGF Kit Catalogue numbers: 6007-002CProduct Lot numbers: 1063782701ARTG Number: 198244
  • Manufacturer
    PerkinElmer

Manufacturer

PerkinElmer