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 situation was reported to roche regarding folate iii reagent kit lot 189895-01 that was released from the production line and did not contain the reagent nor the pretreatment. the frequency of occurence is considered to be very lot (less than 0.1%).