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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Not meeting the current high-dose hook effect expectation in the instructions for use (ifu). the advia centaur systems psa assay range is 0.01-100 ng/ml (ug/l). the advia centaur systems psa ifu states that patient samples with high total psa levels can cause a paradoxical decrease in the relative light units (rlus) (high-dose hook effect). in this assay patient samples with total psa levels as high as 10000 ng/ml (ug/l) will assay greater than 100 ng/ml (ug/l).