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.
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There is variability in results of phenobarbital (phe) reagent and drug calibrator 1. results may vary from -3% to +17% with different reagent and calibrator lot combinations when measured against the established gas chromatography flame ionization detection (gc-fid) method traceable to certified phenobarbital standards.
Model Catalog: 469785 (Lot serial: lots M810440 and earlier); Model Catalog: 469600 (Lot serial: Drug Calibrator part# 469600); Model Catalog: 469785 (Lot serial: Drug Calibrator part# 469600); Model Catalog: 469600 (Lot serial: lots M810083 and earlier); Model Catalog: 469785 (Lot serial: lots M810083 and earlier); Model Catalog: 469600 (Lot serial: Reagent part # 469785); Model Catalog: 469785 (Lot serial: Reagent part # 469785); Model Catalog: 469600 (Lot serial: lots M810440 and earlier)