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
Some lots of synchron systems lipase (lip) reagent (lots m402017 and higher) and amylase (amy) reagent (all in date lots) may fail to calibrate when using synchron systems enzyme validator kit lot m310400.