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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This recall affects customers using the behring coagulation system (bcs). siemens has confirmed that if the cleaner scs vial becomes empty after processing a test for antithrombin assay using the innovance antithrombin kit and the test immediately following is an aptt based clotting assay several results might be falsely shortened. this is a very rare occurrence. customers who are not using innovance antithrombin on the bcs or bcs xp customers are not affected.