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 has confirmed a possible mislabeling of the product name on the front panel of the sample transport module (stm) on some dxh slidemaker stainer coulter cellular analysis systems. some dxh slidemaker stainer systems are incorrectly labeled as "unicel dxh 800 coulter cellular analysis system".