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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Our instructions for use for this product indicate that we will report an assigned range for fibrinogen on the accompanying certificate of analysis (coa). for the two lots identified in this recall only a mean value was reported on the coa. it was determined a recall would be initiated to notify customers of this omission and provide them with an updated certificate of analysis.