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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The access thyroglobulin calibrators are a lyophilized product and as such need to be reconstituted prior to use. the reconstitution time of 30 minutes as stated in the thyroglobulin calibrators instructions for use (ifu) is insufficient for the four affected lots of thyroglobulin calibrators. this has resulted in high patient and control results that are on average greater than 1 standard deviation high.