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 received complaints of failed calibrations on the advia centaur cp system when using bnp kit lots ending in 172. siemens has confirmed that the failed calibration is due to an error on the advia centaur cp master curve card. the master curve card error results in a low calibration deviation outside the specified calibration evaluation range when using kit lots ending in 172 on the advia centaur cp only. an invalid calibration status will prevent bnp results from being generated. the master curve card contained in kit lots ending in 172 for the advia centaur and advia centaur xp platforms is not impacted and there is no calibration issue when using bnp kit lots ending in 172 on those systems.