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 is conducting a field correction for advia centaur system calibrator b lot 40 and below for use with advia centaur prolactin assay on the advia centaur cp system. siemens has confirmed analytical sensitivity of greater than the 0.3 ng/ml described in the instructions for use with multiple advia centaur prolactin reagent lots and multiple calibrator b lots when run on the advia centaur cp only.