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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Lots 904312, 905246, 906507, 907441 and 908161 of the reagent called "AMPLIFIED MYCOBACTERIUM TUBERCULOSIS Direct test" (ref: 39006) of the company BIO MERIEUX are withdrawn from the market following a risk of false-negative result by inhibition of the reaction of amplification on some samples.