Events

Retiro De Equipo (Recall) de Nichols Advantage® Specimen Diluent hGH

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
    2005-05-02
  • 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-dmdiv-nichols-advantage-r-diluant-echantillons-hgh-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 29.04.2005, Nichols Institute Diagnostics removed from the market all batches of the in vitro diagnostic medical device known as Nichols Advantage® Specimen Diluent hGH, reference 64-7756, after an underestimation of approximately 20 % of the final result for the diluted samples. This device is used to dilute the patient samples whose results are higher than the measurement range (> to 30ng / ml). It is used with the Nichols Advantage® hGH assay for the quantitative determination of human growth hormone levels in serum, on the Nichols Advantage® specialized machine. The company has directly notified the recipients of the offending lots by means of the message attached (29/04/2005) (11 KB) validated by the Afssaps .. The competent European authorities concerned are informed directly by the manufacturer. This information is intended for laboratory managers, the directors of health and to the correspondents of reactovigilance for diffusion, if necessary, to the services concerned.

Device

Nichols Advantage® Specimen Diluent hGH

Manufacturer

Nichols Institute Diagnostics
  • Source
    LAANSM