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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The magnesium gen 2 assay ( cat # 06407358190) may have low quality control recovery and frequent failed calibrations upon performing 2 points calibration when used on the cobas c701-702 analyzers after 7 days on board.