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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The impacted lots show an unusual systematic negative biais of 15% when used together with serum based calibrators and controls.The false negative results could pose a patient at risk of not being timely diagnosed for thrombosis and embolism.