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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Manufacturer identifies that the supporting data for sample stability of the cystatin c assay were not sufficient for supporting stability claims in serum and in all plasma types at room temperature 4 degree celcius and -20 degree celcius. new data were generated according to the manufacturer internal guidelines.