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 batches 543017 (per 02.11.03) and 543018 (per 11.04.04) of the reagent called: PATHROMTIN - reference OTXA, following a defect of the activator / kaolin suspension causing the Achieving an abnormally elongated activated partial thromboplastin time (APTT).