Events

Rappel de EnVision +

Selon L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), ce/cet/cette rappel concerne un dispositif en/au/aux/à France qui a été fabriqué par DakoCytomation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • Date
    2005-10-27
  • Pays de l'événement
    France
  • Source de l'événement
    ANSM
  • URL de la source de l'événement
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-references-lots-du-dmdiv-envision-dakocytomation
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Action
    In agreement with Afssaps, the company DakoCytomation removed from the market the references and lots (27/10/2005) (155 Kb) cited in the appendix of the in vitro diagnostic medical device called EnVision +. This measure follows the discovery of an error in the formulation of the system of visualization kits of references and batches mentioned above, which may cause a slight decrease in the signal strength on some samples .. This device is used with mouse or rabbit primary antibodies provided by the user, for the qualitative identification of antigens by light microscopy in paraffin-embedded normal and pathological tissues, sections of tissue cryostats or cell preparations. The company has warned directly the recipients of the references / batches incriminated by means of the attached message (27/10/2005) (11 ko) validated by the Afssaps .. The European competent authorities concerned are informed directly by the manufacturer .. This information s address to laboratory managers, health facility directors and health-vigilance correspondents for dissemination, where appropriate appropriate to the services concerned.

Device

EnVision +
  • Modèle / numéro de série
  • Description du dispositif
    in-vitro_medical_device
  • Manufacturer
    DakoCytomation

Manufacturer

DakoCytomation
  • Source
    LAANSM