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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During in-house stability testing at test point 9 months with lmx lot 3002350 we observed false positive results with a single sample. the sample is expected to test negative for both hla class i and class ii. the sample gave a qualitative result of ci (-) cii (+) indicating a false positive for hla class ii.