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 diagnositcs has confirmed an error in the expected values chart pertaining to the level 2 ph control range for all siemens blood gas instruments namely the rapidpoint 400/405/500 systems rapidlab 1200 series systems rapidlab 248/348/348ex systems rapidlab 800 series systems and the rapidpoint 340/350 systems. due to this error the recovery of ph for rapidqc complete level 2 lot # 362303 is elevated on all siemens blood gas systems. it is also possible that some instruments may on occasion recover ph out of range high. however the published target ranges for all other analytes are unaffected.