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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The low positive control included in the kit can fail to generate sufficient reaction to meet the minimum optical density required by the direction insert. this would result in an invalid test and therfore no results would be reported. any results already reported with acceptable qc criteria are not impacted by this recall.