Events

Recall of EnVision +

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by DakoCytomation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Date
    2005-10-27
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-references-lots-du-dmdiv-envision-dakocytomation
  • Notes / Alerts
    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.
  • Extra notes in the data
  • 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 +
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    DakoCytomation

Manufacturer

DakoCytomation
  • Source
    LAANSM