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 confirmed an issue with the dimension vista gentamicin (gent) flex reagent cartridges k4012. gentamicin results may be falsely elevated 4-10 ug/ml when the prior reagent is one of a number of plasma protein methods. this issue may be present on instruments running gent in combination with a variety of plasma protein methods.