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 stability claim for bicarbonate in the reconstituted control sera precinorm u plus and precipath u plus cannot be met. stability of bicarbonate in reconstituted control:1 day in closed bottle (instead of 2).
Model Catalog: 12149435122 (Lot serial: ALL LOTS NUMBERS); Model Catalog: 12149435160 (Lot serial: ALL LOTS NUMBERS); Model Catalog: 12149443122 (Lot serial: ALL LOTS NUMBERS); Model Catalog: 12149443160 (Lot serial: ALL LOTS NUMBERS)