Events

Retiro De Equipo (Recall) de Nichols Advantage® ACTH

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 DPC France.

¿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
    2005-05-30
  • 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-du-dmdiv-immulite-ace-dpc-france
  • 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 May 27, 2005, the company DPC France withdrew from the market lots 302 and 303 (per 31/08/05) in vitro diagnostic medical device called Immulite ACE reference LKCE1 following the detection of a defect in stability on these lots resulting in a significant decrease in the slope of the adjustments and, not systematically, in control values ​​outside the indicated areas. This device is used for quantitative determination of carcinoembryonic antigen (CEA) in serum, with the analyzer Immulite. This test is an aid in the follow-up of the cancers and in the establishment of a prognosis. The company directly warned the recipients of the incriminated lots by means of the attached message (27/05/2005) (10 ko) validated by AFSSaPS. The relevant European Competent Authorities are informed directly by the manufacturer. This information is intended for laboratory managers, health facility directors and reactive vigilance correspondents for dissemination, where appropriate, to the medical services. concerned.

Device

Nichols Advantage® ACTH
  • Modelo / Serial
  • Descripción del producto
    in-vitro_medical_device
  • Manufacturer
    DPC France

Manufacturer

DPC France
  • Source
    LAANSM