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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Streck informs customers that for cd-chex plus and cd-chex cd34 assays they have issued revised assay sheets for lot 8343. the revision will improve the accuracy of the values assigned for the cd34 marker.