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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In isolated cases ashifted test line of the ibdoc lateral flow test cassette falls outside of the read-out window of the calaoo interpretative software. the result is incorrectly interpreted as test line to control line ratio of 0 and a normal calprotectin value <30 microgram/gram.