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
Customers reported vial-to-vial variation of b-type natriuretic peptide-32 (bnp-32) and creatine kinase-mb (ck-mb) recovery in cardioimmune xl level 1 part number cai-xl 1 lot number cxl16011. within the same kit some vials would recover consistently within the range of published value assignment but other vials would recover dramatically outside the value assignment range (higher for bnp-32 and lower for ck-mb).