Events

Retiro De Equipo (Recall) de Nichols Advantage® Bio-Intact PTH (1-84)

Según L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en France que fue producido por Nichols Institute Diagnostics.

¿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
  • Fecha
    2005-04-12
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-dmdiv-nichols-advantage-r-bio-intact-pth-1-84-nichols-institute-diagnostics
  • Notas / Alertas
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Notas adicionales en la data
  • Acción
    On April 8, 2005, Nichols Institute Diagnostics withdrew lots 62-402622, 62-402622B, 62-402622C, 62-402622D from the in vitro diagnostic medical device known as Nichols Advantage® Bio-Intact PTH (1-84). ) reference 62-7040 following the demonstration that these batches were no longer in conformity with the information indicated in the instructions for use, concerning functional sensitivity, reproducibility, parallelism and recovery. This device is used with the Nichols Advantage® specialized automaton for measuring parathyroid hormone levels in serum, EDTA plasma and heparinized plasma. The relevant European Competent Authorities are informed directly by the manufacturer. This information is intended for those responsible laboratories, the directors of health establishments and the reactive vigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

Nichols Advantage® Bio-Intact PTH (1-84)

Manufacturer

Nichols Institute Diagnostics
  • Source
    LAANSM