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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Biomerieux received reports from some customers about a high rate card or antibiotic terminations for vitek2 ast-gn27 card (#22245). an internal investigation revealed sporadic scratches on the outer surface of the gray transfer tubing of some card of the lot 267215010.