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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There are confirmed customer complaints of low patient sample recovery with dimension tacr flex reagent cartridge lot bb4087 and its linked calibrator lot 3bd029. quality control (qc) materials have not exhibited recovery outside of the expected range. internal complaint testing versus our reference lc/ms method confirmed an average bias of -1.6 ng/ml [-2.1 nmol/l] across the assay range. individual patients particularly samples with lower tacr values (< 5 ng/ml [6.5 nmol/l]) may show more bias due to the typical precision of each methodology.
Model Catalog: DF107 (Lot serial: DF107: LOT BB4087); Model Catalog: DC107 (Lot serial: ); Model Catalog: DF107 (Lot serial: ); Model Catalog: DF107 (Lot serial: FOR ALL); Model Catalog: DC107 (Lot serial: FOR ALL); Model Catalog: DF107 (Lot serial: DC107: LOT 3BD029); Model Catalog: DC107 (Lot serial: DC107: LOT 3BD029); Model Catalog: DC107 (Lot serial: DF107: LOT BB4087)