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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Removal of batches 68577M200 (per 24.04.01) and 68577M201 (per 24.01.01) from the reagent called Imx glycated hemoglobin calibrators - ref. 1A86-01 of the company ABBOTT Diagnostic are withdrawn from the market because of the risk of obtaining values lower than the specifications for the low control. To note: no impact for the patient, in fact, the dosages are invalidated by the out-of-specification values.