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
Beckman coulter has confirmed through internal investigation that the access reaction vessel (rv) lots listed fail to meet a specification for outside diameter on the open ended side of the rv. - the rv lots listed may cause aliquot vessel (av) shuttle motion errors when they are loaded onto the unicel dxc 600i synchron access clinical system through the closed tube aliquotter (cta). there is no impact to patient results. - internal testing did not demonstrate shuttle motion errors on the access 2 standalone system.
Model Catalog: 81600N (Lot serial: B16113TA); Model Catalog: 81600N (Lot serial: B161134H); Model Catalog: 81600N (Lot serial: B161134E); Model Catalog: 81600N (Lot serial: B161233V); Model Catalog: 4767 (Lot serial: B161035D); Model Catalog: 4767 (Lot serial: B161134E); Model Catalog: 81600N (Lot serial: B161035D); Model Catalog: 4767 (Lot serial: B16113TA); Model Catalog: 4767 (Lot serial: B161233V); Model Catalog: 4767 (Lot serial: B161134H)
제품 설명
ACCESS IMMUNOASSAY SYSTEM - ANALYZER CLASS 3;UNICEL DXC 600I SYNCHRON ACCESS CLINICAL ANALYZER;ACCESS SYSTEM ACCESS 2 ANALYZER - CLASS 2;ACCESS2 IMMUNOASSAY SYSTEM