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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As the synchron rf reagent ages it may fail calibration with the condition of "math error" on the calibration report. real time testing in manufacturing indicates the stability claim of 24 months will not be met for lot numbers: m802452 m804502 m807345 and m808329. calibration failures occur at 12 months.