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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Some vials of hemosil pt-fibrinogen hs plus pn 0008469810 exhibit a yellow/brownish color after reconstitution instead of the typical white to off-white color. these vials were observed to cause prolonged prothrombin (pt) clotting times. if an affected vial is used with a patient sample a significant shift in inr greater than 10% could occur with the potential to alter medical treatment.