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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In agreement with Afssaps, J2L ELITECH withdraws from the market lot 221801 (per.31.01.04) of the in vitro diagnostic medical device called: DAKO TPHA SYPHILIS - ref. KD514 (Dako) / 0404-VKD51411 (J2L), due to non-compliance of the instructions included in the enclosures.