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 received complaints of "calibrator insert missing" alerts on dimension vista chemistry 3 calibrator lot 5md004. internal investigation has confirmed that the vial barcode label reads kc130 instead of the correct catalog number kc130a. when this mismatch occurs between the vial barcode label and the instructions for use (ifu) label the "calibrator insert missing" error is triggered and displayed on the dimension vista instrument screen. there is no risk of erroneous results when this issue occurs as no results are generated.