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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Coulter lyse s iii diff lytic reagent lot number 101554f was released for distribution to customers prior to completion of qc testing. the material failed qc testing for hemoglobin (hgb) and white blood cells (wbc).