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
Ortho clinical diagnostics (ocd) has determined that the ortho provue analyzer does not detect that different lots of reagent red cells of the same product have been loaded on the analyzer at the same time. this problem only impacts ortho provue analyzers that had software version 2.15 or 2.16 loaded prior to having software version 3.1 installed by an ocd technical service representative.