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 a report of leaking flex reagent cartridges from tpsa lot 113300bb. if a leaking flex reagent cartridge is used test may be falsely depressed. the magnitude of the inaccuracy and the number of test results affected may vary based on the extent of leaking.