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' complaint investigation has confirmed that the calibration flag "invalid exceeded defined ranges" may be triggered due to the slope value exceeding the acceptable range. the resulting invalid calibration prevents customers from generating ckmb results. when valid calibrations and in range quality control (qc) results are obtained patient results are valid and acceptable for reporting. when an invalid calibration is received qc and patient testing cannot be performed.