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 a high calibration failure rate (percent deviation >5%) with prealb flex reagent cartridge lot 15327ma. this is due to the vista prealb calibration level 6 exhibiting a high bias and leading to failed calibrations.