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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A reference standardization of the roche vancomycin assays was done by the manufacturer against the reference method. it was decided to correct both methods against the reference method. the cobas integra assay was corrected by a reagent modification. the instruction for use of the vancomycin assays already show a method comparison against cobas integra with the changed formulation which is not yet available on the market. this may lead to the assumption that both methods are comparable and may affect the interpretation of results. since the cobas integra reagent is not yet adapted results generated with cobas integra are still up to 20% higher than with cobas c or modular p systems.