Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
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Following biases observed in the results of the french national quality controls beckman coulter has been informed that a study completed by the french competent authority agence nationale de securite du medicament et des produits de sante (ansm) showed diagnosed cancer patients in non-remission of their metastatic disease may have results below the upper reference limit (url) of 31.3 u/ml as stated in the access br monitor instructions for use (ifu).