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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The manufacturer identified a reduction of the on board stability from 42 days to 14 days for the hitachi tinaquant apolipoprotein a1 reagent when used on the roche hitachi 912 and 917 and modular p systems.