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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Siemens has confirmed an increase in the rate of abnormal assay errors (e143: abnromal assay) with the dimension vista rf flex reagent cartridge lot 12283ma. the errors can occur on calibration qc and/or patient sample. any result produced with the abnormal assay error is deemed non-reportable.