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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Internal testing has shown that a sample containing 10.37 ng/ml of troponin i had a calculated concentration of 8.0 ng/ml when diluted and also that samples above this concentration would have lower than expected recoveries when diluted. if dilution recovery tests are run results might not match dilution recovery data provided in the instructions for use (ifu).