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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Testing has shown lower results for patient urine samples and quality control results when using lot 2382 and lot 2378. this causes an increase in negative results with g flags observed for urine samples when using the affected lot numbers.