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 agreement with the Afssaps, the company Randox proceeded, on 22/06/07, with the withdrawal of a lot of the reagent Bicarbonate. Users of these devices affected by this defect in France have received the following letter (22/06/2007) (18 KB) The competent European authorities have been informed of this measure by the manufacturer.