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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Manual does not describe the additional 2ml diluent dispense that occurs while using the f41 function when using software version 2a. this diluent comes out of the blood sampling valve and is a bio-hazard. dk.