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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The dimension vista myoglobin calibrator (myo cal) lot 4fd085 may produce a positive shift in myo qc and patient test results that exceeds their acceptance criteria for this product. siemens has observed a positive shift up to 12% at myo concentrations within and above the reference range of the assay. depening on quality control limits this drift may not be detected.