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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Through monitoring of method performance siemens has determined that the analytical sensitivity claim of 6.6 mcg/dl (1.1 mcmol/l) stated in the instructions for use is no longer valid for dimension total iron binding capacity (ibct) and is modifying that claim to 36 mcg/dl (6.44 mcmol/l).