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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Rare occurrences of falsely lowered k+ results (potential negative bias of 0.6 to 1.2 mmol/l) can occur during cartridge life on patient blood analysis leading to erroneous results with potentially severe impact to patient treatment.