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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Troponin i results in the cardioimmune xl control are measuring approximately 15-30% low in levels 1 and 3 resulting in control measurements which are outside the published value assignment ranges. as a precaution we are proactively recalling all levels associated with lot cxl1301. only troponin i control measurements are affected all other control analyte measurements are recovering within the published value assignment ranges. we are currently investigating the root cause.