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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IMMUNOTECH withdraws from the market batches 89 and 89B (per 13.10.03) of the in vitro diagnostic medical device called: hGH IRMA - reference IM1397, following the possibility of deterioration of the standard liquid range (lot 1001) - contained in the kits of the device - leading to an overdose of the samples .. This device allows the immunoradiometric assay (I 125) of growth hormone in human serum and plasma.