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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Testing has revealed a stability issue that affects on-board assay performance over time. based upon testing we have revised the instructions for the acticlot dpt test to reflect an "on-board" rehydrated stability of the dpt activator reagent of 8 hours at room temperature.