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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According to the complaint sample measurement is done using flexq and the registration receipt barcode is created automatically and customer can see a patient's data directly on the analyzer using the registration receipt barcode. in this case when the registration receipt barcode was read by the analyzer the analyzer presented the result from a different patient. the incident could not be reproduced.