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 is withdrawing lot 06A (per 26.10.01) from the market for the reagent called 17 - OH - PROGESTERONE / reference 17-OHP-NN, following the presence, in some sets, of lot 03A of standards and controls instead of batch 02W, resulting in a failure of the assay.