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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Beckman coulter inc. (bec) has identified that certain lots of folate calibrators a14207 (lot numbers: 112788 115741 118917) and folate who calibrators a98033 (lot numbers: 122651 123635 219962) show reduced stability and do not meet expiration date claims. this calibrator instability can potentially result in falsely elevated patient results.