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 diagnostics has received complaints of positive shift of patient and qc results when the alti assay is calibrated with specific lots of dimension enzyme ii calibrator. internal investigation has confirmed that patients quality control and proficiency testing material all demonstrate a similar shift of up to 10% in comparison to results obtained using earlier calibrator lots. the shift began with lot 4md047.
Model Catalog: DC143 (Lot serial: 6AD054); Model Catalog: 10476170 (Lot serial: 4MD047); Model Catalog: DC143 (Lot serial: 5LD051); Model Catalog: 10476170 (Lot serial: 5LD051); Model Catalog: DC143 (Lot serial: 5JD069); Model Catalog: 10476170 (Lot serial: 5JD069); Model Catalog: DC143 (Lot serial: 5HD010); Model Catalog: 10476170 (Lot serial: 5HD010); Model Catalog: DC143 (Lot serial: 5GD050); Model Catalog: 10476170 (Lot serial: 5GD050); Model Catalog: DC143 (Lot serial: 5FD017); Model Catalog: 10476170 (Lot serial: 5FD017); Model Catalog: DC143 (Lot serial: 4MD047); Model Catalog: DC143 (Lot serial: 5CD052); Model Catalog: 10476170 (Lot serial: 5CD052); Model Catalog: 10476170 (Lot serial: 6AD054); Model Catalog: 10475527 (Lot serial: 5DD026); Model Catalog: KC321 (Lot serial: 5DD026); Model Catalog: 10475527 (Lot serial: 5LD061); Model Catalog: KC321 (Lot serial: 5LD061); Model Catalog: 10475527 (Lot serial: 5JD058); Model Catalog: KC321 (Lot serial: 5JD058); Model Catalog: 10475527 (Lot serial: 5GD004)
제품 설명
DIMENSION CLINICAL CHEMISTRY SYSTEM- ENZYME II CALBIBRATOR (ENZ II CAL);DIMENSION XPAND SYSTEM-ENZYME II CALIBRATOR (ENZ II CAL);DIMENSION EXL SYSTEM-ENZYME II CALIBRATOR (ENZ II CAL);DIMENSION VISTA SYSTEM- ENZYME CALIBRATOR