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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A change must be made to the glucose urine application of the cobas c501 unit of cobas 6000 analyzer due to precision problems and outliers when using aqueous urine control materials at a concentration level of 1.4 mmol/l.