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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When samples are prepared using the prepplus or prepplus 2 sample preparation systems and then run on a flow cytometer there is imprecision in the absolute counts on only the first tube in a run when compared to the rest of the tubes in the same run. the issue may generate erroneous results for the reported parameters assayed on the sample in the first tube of the flow count worklist.