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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During the investigation of an issue from a customer complaint it was found by the manufacturer that the daily cleanup sample can fail in deleting samples which are older than the configured retention period in the cobas it middleware. some samples which have been ordered from the lis and remain with open tests may not be deleted. open tests are those for which results did not complete the processing cycle including transmission to lis.