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 received customer complaints regarding the dimension vista assay enzymatic creatinine flex reagent cartridge. siemens has confirmed an issue which may cause enzymatic creatinine (ecrea) results to be falsely depressed up to 0.4 mg/dl or falsely elevated up to 0.6 mg/dl across the assay range.