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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Affected lots of solution packs were produced with a wrong conductivity value encoded into the chip. this causes a minor negative bias for the hct (hematocrite) measurement of 1 to 2% and following failure of the air detection system.