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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Manufacturer has identified an error on the advia centaur confirmatory card that is included in advia centaur hbsagii reagent lot 109056 (kit lots 55825056 56167056 and 56244056). the error causes an interpretation of 'invalid' and a flag of 'conf n/a' when the hbsagii positive control is tested with the hbsagii confirmatory (conf) assay.