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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In isolated cases when ecrea is processed immediately after the weekly automated acid clean routine during probe test there is the remote potential for an elevation of greater than 15 percent in the ecrea result. investigation has determined that the processing of ecrea quality control (qc) after the probe test will identify a potential elevated ecrea result.