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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An anomaly with all versions of observa has been identified that can cause positive and negative accessions to not be sent to the bottle lis. this anomaly can occur when results are received from the bact/alert 3d when observa is running a scheduled bottle lis link transmission and where the bottle lis connection has been configured to send new test results.