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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Sysmex america inc has become aware that the basophil percent and absolute count (baso%/baso#) for e-check(xe) (part #201-6001-0) is occasionally not recovering within the assay range for level 1 of lot 5336 expiration date february 22 2016. level 2 and level 3 are not affected and are recovering within assay ranges.