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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There may be an incorrect side label on a small percentage of the advia centaur systems bnp readypacks from reagent lot 038174. incorrectly labeled readypacks are included within kit lots 43305174 43278174 43306174 and 43279174. the human-readable side label may incorrectly identify the readypack as advia centaur systems ft4 readypack. the readypack end label and the barcode end label correctly identify the readypack as the advia centaur systems bnp readypack and the readypack will scan correctly as bnp when loaded onto the advia centaur systems. the kit boxes are correctly labeled as bnp. other advia centaur bnp kit lots ending in 174 are not impacted.