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.
데이터 추가 비고
원인
The absolute range of igfbp-3 levels determined using dsl-10-6600 igfbp-3 elisa lot number 992743 is 3196 -10007 ng/ml. this is approximately 1.7 fold higher than the absolute range reported in the ifu (1500 - 5600 ng/ml).