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 use of aquios lyse reagent kit lot numbers 6040014k and 6040015k may lead to an increased generation of notifications and flags when used on the aquios cl when running the aquios tetra application. the issue could lead to an increase in the number of samples requiring review and re-runs with a potential delay to the reporting of results. depending on the specimen age a new blood specimen may be required.