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.
데이터 추가 비고
원인
Siemens healthcare diagnostic has confirmed through internal investigation of lot 084 that the solid phase in some of the lot 084 tni-ultra readypacks is darker in appearance.
Model Catalog: 02789602 (Lot serial: KIT LOTS ENDING IN 084); Model Catalog: 02789602 (Lot serial: KIT LOTS ENDING IN 078); Model Catalog: 02789602 (Lot serial: KIT LOTS ENDING IN 083); Model Catalog: 02790309 (Lot serial: KIT LOTS ENDING IN 082); Model Catalog: 02789602 (Lot serial: KIT LOTS ENDING IN 082); Model Catalog: 02790309 (Lot serial: KIT LOTS ENDING IN 079); Model Catalog: 02789602 (Lot serial: KIT LOTS ENDING IN 079); Model Catalog: 02790309 (Lot serial: KIT LOTS ENDING IN 078); Model Catalog: 02790309 (Lot serial: KIT LOTS ENDING IN 084); Model Catalog: 02790309 (Lot serial: KIT LOTS ENDING IN 083)
제품 설명
ADVIA CENTAUR XP SYSTEM - TROPONIN I ULTRA (TNI-ULTRA) ASSAY