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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Erroneous results may occur as a result of a software issue when specific conditions occur with the phadia 250. the issue can occur with all versions of the phadia prime software up to and including version 2.1.4. the issue will cause software to disregard default dilution factors for rejected samples when using the "ok to all" function for retesting of samples if specific criteria are met.