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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On jan 25/01 company became aware of issue with lot #127945 through an account complaint.Retention sample confirmed defect. packages were mislabeled due to transposition of numbers error on sublot number recrd.