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 has received multiple customer complaints for invalid calibrations with advia centaur systems brahms procalcitonin reagent kits. this issue affects the advia centaur/xp/xpt and advia centaur cp systems. the 'calibrator ratio' parameter may fall below the acceptable range resulting in an invalid calibration preventing customers from generating procalcitonin results.