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 has confirmed a software defect in the stratus cs acute care diagnostics system and stratus cs 200 acute care diagnostics system regarding testpak calibration and quality control (qc)status when a testpak is due to expire within 48 hours. depending on the calibration status either an above assay range (aar) or an inaccurate value could potentially be reported when running a testpak that is due to expire within 48 hours.