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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Customers have reported an abnormally high frequency of artifacts in the gram crystal violet product (sometimes large spherical and easy to distinguish at other times smaller and more difficult to distinguish from gram positive cocci). because those artifacts may be misread as gram positive cocci a misreporting of gram stain results could occur. this misreporting could lead to initiation of incorrect patient treatment prior to the availability of a corrected gram stain or final culture result.