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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The manufacturer has noticed that the level 1 product lyphochek coagulation control may not meet the stability data in respect of the reconstituted vials when properly closed and stored at required temperatures as indicated in the data sheets.