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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Siemens has confirmed that immulite 2000/immulite 2000 xpi intact pth kit lot 320 can exhibit an average negative bias of up to -39% at ipth concentrations <20 pg/ml with serum and edta patient samples vs. a reference kit lot.