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
Sysmex has become aware of an increase in imprecision of lymphocyte (lym # lym %) and monocyte (mono # mono %) counts with the xn check hematology control. all other parameters on the assay sheet are not affected. patient results are also unaffected.