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
Beckman coulter inc (bec) has confirmed that the system manager on the unicel dxh slidemaker stainer coulter cellular analysis system software version 1.5.1.0 will not allow the customers to change the time and date backward when following the instruction for use (ifu). this affects the ability of an operator to make the necessary time change adjustments for the changes from daylight savings time (dst) to standard time.