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 monthly cleaning procedure (mcp) maintenance under certain circumstances may result in residual cleaning solution (bleach) in the reagent probe 1 (rp1) fluidics and the water reservoir causing false results. tests affected are total human chorionic gonadotropin (thcg) progesterone and prostate specific antigen (psa). the daily cleaning procedure (dcp) under certain circumstances may result in residual cleaning solution (bleach) in the water line causing false results that use water for test processing. test affected is toxoplasma m (toxo m).
Model Catalog: 078-A001-14 (Lot serial: ); Model Catalog: 04911855 (Lot serial: ); Model Catalog: 09066916 (Lot serial: ); Model Catalog: 078-A010-07 (Lot serial: ); Model Catalog: 078-A001-14 (Lot serial: N/A FOR ALL); Model Catalog: 04911855 (Lot serial: N/A FOR ALL)