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 high calibrator for calibrator a lot ca77 is under-recovering to the assigned target for the advia centaur total t4 assay. internal investigations showed that the average bias of the high calibrator-to-target is -20% with an observed range of bias from -21% to -19%. the under-recovery of the high calibrator is leading to an elevated response in the high end of the total t4 assay which may be reflected in level 3 quality controls (15.8ug/dl for biorad lyphochek control level (40243)) being out of range high. internal investigations showed that the average bias of the level 3 control-to-target is 16% which had an observed range of bias from 10% to 20%.