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 is currently investigating confirmed reports of calibration slope failures on various lots of the advia centaur systems t4 reagent. a failed calibration slope will result in an invalid calibration status which will prevent t4 patient results from being generated. if the calibration slope passes and controls are within laboratory limits patient results are considered valid and may be reported.