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 healthcare diagnostics ltd. has determined that the dose at which a patient sample may hook for lots 123 and above is lower than indicated in the original instructions for use (no hook effect seen up to 600000 miu/ml instead of claimed 2860000 miu/ml).