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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A wrong titration method was used when producing the probe mix for sk109 vial 3. this has resulted in the her2 dna probe concentration being approximately 4-5 times lower than usual for this product.