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 corrective action was to revise the instructions for use to recommend to the end user to sterile filter histopaque prior to use if separated cells will be subsequently cultured or if sterility is a requirement for down stream use of the cells. this action resulted in a recall to notify any recipients of in-vitro diagnostic labelled histopaque batches still within their expiry dates as of november of 2009 of this change to the instructions for use.