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 232056002 (per 24.08.02) of the reagent called Stratus CS / TestPak Cardiac Troponin I - ref. CCTNI, following a high background resulting in an increase in the results with possibility for normal samples, to exceed the threshold value (0.06ng / ml). This reagent is used to test cardiac troponin I on the Stratus CS analyzer.