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 an internal investigation the ceruloplasmin assay (cat #20764663322 lot 19395501/only lot imported in canada) will need to have the sensitivity limit parameter changed when used on the cobas c311/c501/c502/c701/c702 until further notice. higher signals could be generated causing problems with the upper sensitivity limit that could generate error alarms that would prevent performing any measurements.