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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Under certain circumstances the cobas u 411 is transmitting to the lis the lowest possible value of the assigned range table in combination with the t-flag. generally the lowest possible value of the range table is "neg". as a result false negative results could be present in the lis patient file which could have an impact on the medical decision.