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 2d barcodes on the aquios tetra-1 and tetra-2+ reagent vials and the aquios lysing reagent incorrectly encoded thirty (30) days for the open container stability. the correct open vial stability claim as stated in the instructions for use (ifu) is ninety (90) days for the aquios tetra-1 and aquios tetra-2+ reagents and eighty (80) days for the aquios lysing reagent kit.