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
Internal testing conducted by the manufacturer has determined that advia centaur v. 4.0 and advia centaur xp v 6.0 system software is missing range flags and no reflex testing after restoring definition updated.
Model Catalog: 078-A001-14 (Lot serial: VERSION 4.0 SOFTWARE); Model Catalog: 04911855 (Lot serial: VERSION 4.0 SOFTWARE); Model Catalog: 078-A010-07 (Lot serial: VERSION 6.0 SOFTWARE); Model Catalog: 09066916 (Lot serial: VERSION 6.0 SOFTWARE)