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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Detector calibration packs from lot number 950413 may calibrate the bioplex 2200 detector module incorrectly leading to the possibility of low count errors for patient samplesassay calibratorsqc material.