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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Complaints have been received about the values of the kit control (c1) referenced in the mle card. during the investigation (pr 811293) it was discovered that the dose value range and the confidence interval of the c1 control referenced in the mle card was different than the c1 control referenced in the kits. the dose value range and the confidence interval reported in the mle card are incorrect (dose value range: 3.45 ng/ml confidence interval: 2.67-4.23 ng/ml).