Events

Retiro De Equipo (Recall) de Alkaline Phosphatase

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
    2005-07-13
  • 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-phosphatase-alcaline-biocode-hycel
  • 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 July 11, 2005, the company BIOCODE HYCEL withdrew from the market lot 016 (per 30/04/2006) of the in vitro diagnostic medical device called Alkaline Phosphatase reference R5A650A following a filling to 50 ml of reagent bottles REAG1 ( buffer) instead of 40 ml. This defect causes an overflow of the liquid during the preparation of the working solution by pouring the REAG 2 (substrate) into the REAG 1 (buffer) vial. This device is a kit used for the quantitative determination of the alkaline phosphatase in the serum or plasma samples. The company has directly notified the recipients of the offending batch by means of the attached message (11/07/2005) (21 KB) validated by Afssaps. 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

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

Manufacturer

BIOCODE HYCEL
  • Source
    LAANSM