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 america inc. has become aware that the ipf% level 2 expected range was incorrectly reported for xn check lot numbers 6067 and 6068. the ipf% level 2 mean values are correct. appilcable instruments are xn-series (xn-10 xn-20 xn-11 xn-21) analyzers. assay sheets have been amended with the correct ipf% level 2 expected ranges. all other parameter means and expected ranges are correct. use of the original assay sheet may falsely indicate that the control is recovering outside of the true expected range.