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 DADE BEHRING withdraws from the market the batch CTF4 (per 28.08.02) of the reagent called OPUS MODULES - Troponin Test I (cTn) / reference OQVY45, following a drift of the background noise which can cause a invalidation of the calibrations (ratio B / A1 does not meet the specifications of the method). This reagent allows the determination of cardiac troponin I with OPUS and OPUS Plus systems.