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
The shield for the single-tube station on the dxh instrument may interfere with sample aspiration in the open vial position. the mechanical interference between the shield and the right (green) position of the single-tube station can cause the tube holder to remain in the down position during aspiration and then spring up resulting in the dislodging of an open vial. this mechanical interference may result in a biohazardous spill. the left (lavender) position tube holder of the manual station is not impacted by this issue.
Model Catalog: B24802 (Lot serial: SW VERSION 3.1.1.0); Model Catalog: 629029 (Lot serial: SERIAL # AS23151); Model Catalog: B24802 (Lot serial: SERIAL # AS23151); Model Catalog: 629029 (Lot serial: SW VERSION 3.1.1.0)