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 manufacturer has identified during an internal investigation that multiple chemistry assays (alanine aspartate creatine kinase-mb glutamate dehydrogenase and ammonia test kits) are showing possible interference with patient samples containing a certain amount of sulfasalazine/sulfapyridine.