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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Two complaints have been received (sr3202151 and sr3227137) from two different laboratories concerning the missing information in the ifu (instructions for use). the missing information concerns the drying step before deparaffinization where the ihc (immunohistochemistry) slides must be dried in an oven for 1 hour at a specific temperature.