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
Iris international has determined that sample probe misalignment or bending on the ichemvelocity may lead to a remote possibility of false negative results due to inadequate strip dosing. the investigation was initiated based on customer complaints for control failures.
Model Catalog: 800-7719 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 800-7720 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 800-7167 (Lot serial: >10 NUMBERS CONTACT MFG)
제품 설명
ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM;ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM BACK INTEGRATED;ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM W LOAD/UNLOAD