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
Possible failure of the factor v leiden control template (positive control) included in the factor v leiden kit for use with the lightcycle 2.0 instrument.The factor v leiden control template may fail to meet the validity criteria set by the macro component of the lightcycler 2.0 instrument.