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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원인
Erroneous results compared to the specif. of up to 40 mmol/l a reduced linearity of only 32 mmol/l was confirmed.Linearity cannot be reached reagent degrading faster than expected.