Events

Recall of Transport and Preservation Medium CMDH Test

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 ALPHAPATH.

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
    2013-07-17
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/milieu-de-transport-et-de-conservation-cmdh-test-alphapath-retrait-de-produit
  • 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 accordance with the Sanitary Policy Decision taken by the ANSM on 02.07.2013, the company ALPHAPATH informed the users of the CMDH transport and conservation medium of the withdrawal of this product. The users concerned, in France, received the attached mail (17/07/2013) (193 KB). This information is addressed to the directors of health establishments and local correspondents of reactovigilance for diffusion to the concerned services. Read too. Erratum - Suspension of marketing of CMDH transport and preservation media put on the market by ALPHAPATH and Cyt All, and Fixcytol put on the market by CYTOMEGA (22/07/2013) (169 KB) (22/07/2013 )

Device

Transport and Preservation Medium CMDH Test
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    ALPHAPATH

Manufacturer

ALPHAPATH
  • Manufacturer Parent Company (2017)
    Alphapath
  • Source
    LAANSM