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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Access hybritech free psa reagent ref 37210 all lots: the instructions for use indicates patient samples that are elevated beyond the measuring range of the assay can be manually diluted using access hybritech free psa calibrator s0 or wash buffer ii to determine absolute sample concentration. wash buffer ii is also used with the unicel dxi onboard dilution feature for diluting patient samples. beckman coulter has identified a positive bias in test results when comparing elevated free psa patient samples diluted with wash buffer ii to samples diluted with access hybritech free psa calibrtor s0.