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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Following internal investigation of customer complaints the manufacturer identified a situation where when the cobas 8000-e602 analyzer was running sw versions 05-01 05-02 and 06-02 the system may behave incorrectly after deleting an immunoassay application while the corresponding reagent pack is still onboard of the cobas e602.