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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Quality data sources have indicated that specific lots of the cobas 4800 hpv amplification/detection kits ce-ivd are generating an increase frequency of invalid positive control results for multiple channels. in order to limit the potential of invalid pc generation the shelf life of these products were shortened to 6 months pending investigation of the root cause.