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 body fluids rbc (red blood cells) parameter may fail to meet limit of blank (lob) limit of detection (lod) and limit of quantitation (loq) specifications and the body fluids tnc (total nucleated cell count) parameter may fail to meet limit of blank (lob) specifications on the unicel dxh 800 and 600 coulter cellular analysis systems.