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
An inaccurately low result was reported for a vancomycin patient sample on cobas c 501. this was confirmed by roche. detailed investigations revealed that the sample contains a component which inhibits the drug labeled enzyme glucose-6-phosphate dehydrogenase (vanc-g6pdh) in the emit assay.
Model Catalog: 04491050190 (Lot serial: All lots.); Model Catalog: 04642481190 (Lot serial: All lots.); Model Catalog: 04642490190 (Lot serial: All lots.); Model Catalog: 05842310190 (Lot serial: All lots.)
제품 설명
VANC2 (ONLINE TDM VANCOMYCIN FOR ROCHE/HITACHI COBAS C 311 AND C 501/502 SYSTEMS