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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In agreement with Afssaps, Roche on 04/04/07 removed part of a batch of CRP LX reagent due to a labeling problem. The users of this device concerned by this defect, in France, have received the attached letter (04/04/2007) (322 KB) This information is intended for laboratory managers, directors of health establishments and correspondents local reactive vigilance for dissemination to relevant biology departments.