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 is conducting a recall for the total protein 2 reagent (urine)(upro2) lot 149411 on the advia chemistry systems. due to precipitation of the reagent indicator dye in this lot an increase in failed calibrations and quality control failures has been observed. these failures will result in no patient result being reported with the affected kits.