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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Cobas 4800 hpv master mix formulation error that may lead to an increased rate of invalid runs with the cobas 4800 hpv amplification/detection kit. there is no safety impact from this issue as no erroneous results would be generated for clinical specimens.