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 has determined that five (5) lots of dimension ammonia assay (df119) and three (3) lots of dimension vista ammonia assay (k3119) flex reagent cartridges do not meet the 60-day calibration interval claim due to reagent instability and may show an abnormal assay message. these lots may exhibit accuracy shifts for patient and/or quality control results. this may cause laboratories to recalibrate more frequently than the 60-day claim in the ifu.
Model Catalog: DF119 (Lot serial: BA7250); Model Catalog: 10711991 (Lot serial: FB7152); Model Catalog: DF119 (Lot serial: EA7223); Model Catalog: 10711991 (Lot serial: EA7223); Model Catalog: DF119 (Lot serial: BA7194); Model Catalog: 10711991 (Lot serial: BA7194); Model Catalog: DF119 (Lot serial: EB7180); Model Catalog: 10711991 (Lot serial: EB7180); Model Catalog: DF119 (Lot serial: FB7152); Model Catalog: 10711992 (Lot serial: 16265AB); Model Catalog: K3119 (Lot serial: 16265AB); Model Catalog: 10711992 (Lot serial: 16225BB); Model Catalog: K3119 (Lot serial: 16225BB); Model Catalog: 10711992 (Lot serial: 16187BE); Model Catalog: K3119 (Lot serial: 16187BE); Model Catalog: 10711991 (Lot serial: BA7250)
제품 설명
DIMENSION XPAND SYSTEM - AMMONIA ASSAY;DIMENSION EXL SYSTEM - AMMONIA ASSAY;DIMENSION CLINICAL CHEMISTRY- AMM ASSAY;DIMENSION VISTA SYSTEM - AMMONIA ASSAY