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 has confirmed the immage immunochemistry systems apolipoprotein a-1 (apa) reagent (lot number m404171) contains an important product notification insert with incomplete information. the notification references only apa lot number m401225 but should reference apa lot numbers m401225 and newer. apa lot number m404171 calibrated with apo cal lot number m305133 may produce inaccurate results (>6% low bias).