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 received complaints regarding a perceived increased rate of reactive results with specific advair centaur hbct assay kit lots that do not correspond with other hbv serological markers. hbct readypack lot numbers ending in 044 045 and 046 do not meet the specificity claims in the ifu. product code 07566733 is used with the advia centaur advia centaur xp and advia centaur cp systems.