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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Reports of increased rate of calibration failure for affected lots of phosm reagent. the failure flags as range for aqua cal level 2 when rate values for cal level 2 are more negative than -7 (the acceptable aqua cal 2 range is +7 to -7). aqua cal level 2 is the zero level calibrator for phosm.