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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Access testosterone reagent kits have included document a82247a ("kit stuffer") since december 2009. the kit stuffer incorrectly states that unicel dxc600i instruments are not implicated in a product corrective action regarding reagent contamination. dxc600i customers were informed of the reagent contamination issue in october 2007 in a recall letter (pca-c-e-1051) but the specific reference to the dxc600i instrument was inadvertently omitted from the testosterone kit stuffer.