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 healthcare diagnostics has confirmed an increase in the rate of abnormal assay errors (e143: outside absolute results monitoring limits) with the dimension vista phenytoin (ptn) flex reagent cartridge lots 14163ab and 14181ac. the errors can occur on calibration qc and/or patient samples.