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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A slight decrease of the staining intensity and percent positive cells was observed. no cases demonstrating complete negative (false negative results) were observed. the investigation results support that the expiration date for the affected lot numbers should be set to 18 months from the date of manufacture instead of the currently marked 24 months.