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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Potential issue with the cobas 8000 data manager system (all versions) where the option "automatic patient masking when qc error" option does work correctly. this functionality does not work if the results for the last measured control level for this test is valid. as a consequence the results for the measured samples would not be released and forwarded to host due to the qc error.