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 received customer feedback regarding the clinical utility of advia centaur brahms procalcitonin (pct) quality control level 1. quality control level 1 currently has a range of +/- 50% of the target. siemens internal investigation confirmed that this range was incorrectly set. siemens has revised the range of advia centaur brahms procalcitonin (pct) quality control level 1 to +/- 30% of the target. a review of test data confirmed the assay is capable of achieving a narrower range of +/- 30% of the target.