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, the Diagast company, informed the 23/04/2008, the users of the reagent DuoLys used to carry out the blood groups ABO and phenotypes Rhesus / Kell, of a risk of false positive results. The users of this device concerned by this defect, in France, received the attached mail (25/04/2008) (19 KB). The competent European authorities have been informed of this measure by the manufacturer. This information is intended for laboratory managers, directors of health establishments and local correspondents of reactive vigilance for distribution to the concerned biology departments.