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 package insert that accompanies qualicheck qc reagents used with abl 70/77/555 analyzers listed incorrect control ranges for hematocrit testing. the stated range was too low to generate accurate results.