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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When a reagent vial with an unreadable barcode is loaded on a reagents rack on ih-1000 (software version 04.07.02) and a test is performed despite the fact the first reagent is correctly pippetted the instrument will pipette in the vial with unreadable barcode for all the remaining wells.