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 determined that kap lot m611357 may demonstrate inaccuracy or imprecision in control samples containing low concentration kappa light chains. kap control failures can potentially lead to a delay in reporting kappa light chain patient results. reassessment of past results is not required. patient results reported under acceptable calibration and quality control evaluation are not affected by this issue.