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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Manufacturer has confirmed inaccuracy and imprecision when the dimension tacr flex reagent cartridge sits idle on the analyzer / instrument for 2 days or more. this imprecision typically presents as one or more elevated tacr results following a period of instrument inactivity. subsequent results from the same well may exhibit depressed values.