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 has conducted an internal investigation of calibration failures due to slope errors that are not resolved with routine maintenance. a low frequency occurrence of this issue has been confirmed for certain stratus cs testpak lots as they approach their expiration date.