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 gem premier 3500 system has identified that the patient id from the previous sample was transmitted to the wrong file on their gem premier 3500 instrument. this event occurs specifically when they misuse the gem premier 3500 barcode gun by repeatedly clicking the gun which can potentially cause the instrument under certain conditions to attach the test results to an incorrect patient id.