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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Over range detection and correction feature does not perform correctly for glucose chemistry when "other" selected with software v1.0 & v1.2. results could be elevated as much as twice actual value.
Model Catalog: A23724 (Lot serial: Software version 4.5); Model Catalog: A20463 (Lot serial: Software version 1.0); Model Catalog: A27331 (Lot serial: Software version 1.2)