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 Beckman Coulter withdraws from the market the batch T201091 (per 30.04.03) of the reagent called: SYNCHRON SYSTEMS / Gamma GT reagent - ref.442650, following the obtaining of abnormally high results with out-of-specification values for the sera of quality control.