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
Potential to obtain falsely low results without a flag in samples with high turbidity and high kinetic activity. this issue affects only ckmbl ldh and amylase (pancreatic and total) assays.
Model Catalog: 04525299190 (Lot serial: All lots); Model Catalog: 20766623322 (Lot serial: All lots); Model Catalog: 03004732122 (Lot serial: All lots); Model Catalog: 03002209122 (Lot serial: All lots); Model Catalog: 11876473316 (Lot serial: All lots); Model Catalog: 03183742122 (Lot serial: All lots); Model Catalog: 11876562316 (Lot serial: All lots)