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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Imprecision and erroneous results could be generated by identified lots of calcium assays used on the cobas integra 400/800 cobas c501 cobas c311 or cobas c111 analyzers due to precipitate in the r2 reagent bottle.