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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Changes in the specification in the instructions for use of the theophylline test. the new lower detection limit is 0.8 ug/ml - 40 ug/ml. the theobromine concentration in section "limitations-inteference" of the instrusctions for use has been modified to 20 ug/ml.