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 confirmed increased assay imprecision and a positive bias (increase in index values) in the low end of the assay with the advia centaur systems hbc total (hbct) assay reagent lot 100064. the increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in false reactive results.