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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A potential non-conformity has been identified related to vitek2 gn id test kit: aglu (alpha glucosidase) may have a false positive reaction with some isolates of e.Coli for this lot of gn id test kits which may contributes to the misidentification of these isolates of e.Coli as serratia fonticola.