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.
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In accordance with the sanitary policy decision taken by the ANSM on February 04, 2014 (10/02/2014) (1058 ko), the Fumouze company informed users of the Retroscreen HIV rapid test of the withdrawal of this product. The users concerned, in France, have received the attached mail (10/02/2014) (404 ko). This information is addressed to the directors of health establishments and local correspondents of reactovigilance for diffusion to the concerned services.