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 the cobas 6800/8800 mpx reagent kit (lot 222194) was incorectly packaged within a kit carton labelled as mpx control kit. only a few kits were presenting the erroneous label. there is no impact on the test performance and the reagent cannot be incorrectly used on the instrument.