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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Lot PSR1 of the reagent called OPUS PSA Modules test - reference OWZT (prostate specific antigen assay) of the company DADE BEHRING SA is withdrawn from the market due to a background noise that is too high that could lead to a failure of the calibration.