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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The company BIOMERIEUX withdraws from the market lot 758504001 / per. 19.04.02 of the reagent called VIDAS CA 125 II- reference 30426, following a change in the time of the performances resulting in a slight overestimation of the results and an out-of-specification value of the C1 control.