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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The specimen and prepared sample stability claims stated in the product labeling for the affected product needs to be updated for alignment with current standards and clinical decision-making associated with lymphocyte immunophenotyping results.
Model Catalog: A40051 (Lot serial: ALL TETRACHROME LOTS); Model Catalog: 6607013 (Lot serial: ALL TETRACHROME LOTS); Model Catalog: 6607073 (Lot serial: ALL TETRACHROME LOTS)