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.
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Siemens healthcare diagnostics received customer complaints regarding calibrator a lots 068 and/or 069 for ft4 used on the advia centaur advia centaur xp and advia centaur cp systems. siemens has confirmed that the use of calibrator a lots 068 and/or 069 to calibrate ft4 may result in low recovery of quality control material and patient samples.