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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Recall related to a change in the package insert of the cobas 4800 hpv amplification/detection kits. following review of additional data it was confirmed that all surepath specimens must now be pretreated prior to testing.