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 is informing customers that a rare variant of tsh identified in a small cluster of patients is not detected by the siemens assays. as part of an investigation of unexplained discordant results samples were identified in which the monoclonal antibody used in the reagent failed to detect the tsh molecule. these individuals may have a previously unrecognized functionally normal tsh variant. the observed rate of occurrence during a 30-month time period was 0.6 x 10-7.