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
Software limitations affecting manually loaded reagent cartridges on the cx instruments causing instruments to reveal incorrect expiry dates.
Model Catalog: 756600 (Lot serial: all non-pro software versions); Model Catalog: 468233 (Lot serial: all non-pro software versions); Model Catalog: 756601 (Lot serial: all non-PRO software versions); Model Catalog: 468205 (Lot serial: all non-PRO software versions); Model Catalog: 473513 (Lot serial: all non-PRO software versions); Model Catalog: 759300 (Lot serial: All non- PRO software versions); Model Catalog: 448700 (Lot serial: All non- PRO software versions); Model Catalog: 468243 (Lot serial: All non- PRO software versions)
제품 설명
SYNCHRON CX4 CX4 Delta and CX4 CE Clinical Systems