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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An upward shift in the control value for the syphilis igg 15kda and 47kda markers using the control set(lot 46636) with the reagent/calibrator (lot 961348/46488 and 963411/46593). this shift can result in a control value for the 15kda marker that falls outside of your current manufacturing ranges.