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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Itc has determined that certain lots of hemochron jr. pt cuvettes demonstrate a higher bias than historically observed when compared to laboratory reference instruments. while the lots in question were within specification and met quality control release criteria a shift in bias occurred that was coincident with a change in a lot of raw material used in the reagent formulation.