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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Potential for falsely low mean platelet volume (mpv) by up to 2 fl as a result of incorrect s-cal assay value assignments on control products. the deviation is not clinically significant and will not impact patient management or treatment decisions. the issue is exclusive to the mpv parameter.