Events

Recall of Clearview Simplify D-dimer tests

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 Inverness Medical.

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
    2007-02-23
  • 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-d-un-lot-du-reactif-clearview-simplify-d-dimer-de-la-societe-inverness-medical
  • 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, Inverness Medical informed, on 21/02/2007, the users of the Clearview Simplify D-dimer tests, the recall of a batch following a decrease in sensitivity. The users of this device concerned by this defect, in France, have received the attached mail. (21/02/2007) (77 ko) The competent European authorities have been informed of this measure by the manufacturer This information is intended for laboratory managers, health facility directors and local correspondents for reappurovigilance for concerned biology services.

Device

Clearview Simplify D-dimer tests
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    Inverness Medical

Manufacturer

Inverness Medical
  • Source
    LAANSM