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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There is a potential for erroneously high platelet (plt) rbc mpv and hematocrit (hct) results to be generated. the erroneous results may occur on the first aspiration of a tube and may occur without instrument generated messages. testing has demonstrated an average probability of occurrence of erroneous elevated platelet counts on the first aspiration of a specimen tube of 0.6% with a 95% confidence interval of 0.21% to 0.99%.