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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CIS BIO INTERNATIONAL withdraws lot 10B (expiry 01/10/2003) from the market of the in vitro diagnostic medical device called RENIN III GENERATION, following a calibration defect which leads to an overestimation of the patient results of the order of 20%. This device is a kit for the radioimmunometric assay of active renin in human plasma.