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 confirmed a low and/or out of expected basophil percent (ba%) recovery range for the 5c abnormal ii cell control lots referenced. this issue only affects the 5c abnormal ii cell control basophil percent (ba%) recovery. the laboratory may fail quality control for the ba% at the concentrations in the 5c abnormal ii cell control only.