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.
데이터 추가 비고
조치
In agreement with Afssaps, the Olympus company proceeded, on 21/02/07, to the recall of 7 batches and to the reduction of expiry of 4 lots of Total Bilirubin reagent, following a change of aspect of the reagent. The users of this device concerned by this defect, in France, received the attached mail (21/02/2007) (52 KB).