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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Batches 113 and 115 of the reagent called CRP Bireactif - ref. B01744 from BIOTROL DIAGNOSTIC are withdrawn from the market due to an error in the concentration of PEG used for the manufacture of the buffer included in the reagent kit, leading to a risk of erroneous results for patient samples (over- or underestimation obtained from random way).