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 has confirmed that some stratus cs acute care ccrp testpaks in named lots may generate slope errors which result in a failed calibration for the hscrp assay. as a result patient and quality control results cannot be generated.