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 access ostase ifu incorrectly specifies the open reagent pack stability as 28 days. the correct open reagent pack stability for this assay is 42 days. the assay protocol file (apf) uses the correct open reagent pack stability value.