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 1FD012 (per 01.06.02) of the reagent Dimension PALB Calibrator / ref. DC50, due to the possibility of calibration failure (upper part of the nonlinear calibration curve) leading to an impossibility to issue results for the patient samples.