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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Two lot numbers of reagents or strips are allowed to be tested while performing qc testing on the echo. the result is that the final lot tested will pass qc even though it did not undergo complete qc testing.