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 kit box and calibrator tubes are correctly labelled with lot 141010 but the display and reports on the bio-flash system indicate lot "141009". this was caused by an error in the barcoding of the calibrator tubes which also assigned target values to the calibrators from lot 141009 rather than from lot 141010. the target values of the two lots are comparable. therefore results previously reported are not impacted by this recall.