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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Siemens has received complaints of customers experiencing slopes greater than 1.05 when calibrating flex reagent cartridge lot 12905ad. the acceptance criteria for slope is 0.95 to 1.05. a calibration that results in a slope failure prevents the vanc (vancomycin) assay from being run on the dimension vista system until a successful calibration can be achieved.