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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Bar code rings were mistakenly used in the manufacture of a small number of lot 9284ac2 cpomprehensive metabolic panel rotors at the very end of the manufacture run. this resulted in incorrect calibration factors being applied to the calculation of the measured values for serum creatinine on a sub-set of rotors. serum levels will be slightly lower.