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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Beckman coulter has identified problem with the flow-count fluorospheres reagent lot number 7548054f. the reagent is showing intermittent absolute count recovery failures for mid-point closed vial testing with immunotrol control cell on the two color panel.