Events

Retiro De Equipo (Recall) de Creatinine

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 BIOCODE HYCEL.

¿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
    2005-10-27
  • 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-d-un-lot-du-dmdiv-creatinine-biocode-hycel-france-sa
  • 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 October 26, 2005, Biocode-Hycel France SA withdrew from the market lot 014 (expiry 03/2007) of the in vitro diagnostic medical device called Creatinine (references BC4002 / 200 and BC4002 / XS). This measure follows the detection of an instability of this batch with the preservation resulting in an abnormal degradation of the performances resulting in a decrease of the sensitivity. This device is used for the quantitative determination of the creatinine in the urine, serum or plasma. The company has directly notified the recipients of the offending lot by means of the attached message (26/10/2005) (19 KB) validated by Afssaps. The competent European authorities concerned are informed by the Belgian competent authority. This information is intended for laboratory managers, the directors of health establishments and the reactovigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

Creatinine
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    BIOCODE HYCEL

Manufacturer

BIOCODE HYCEL
  • Source
    LAANSM