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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Some vials of dimension loci cardiac troponin i calibrator under-recover troponin i resulting in over-recovery of qc and patient samples following calibration. testing on patient samples demonstrated an average upward shift of 24% (range 1%-33%) when compared to an unaffected lot.