U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
원인
Version 2.6 software was released however it will not properly handle adjustment slopes.
조치
Recall Technical Bulletins were sent out on 6/13/2003 to all Immulite 2000 users instructing them to not install the provided version 2.6 software.
Software was distributed to Immulite 2000 users throughout the nation. These units are found in hospitals and clinics. Software was also distributed to the firm''s service representatives.
제품 설명
Immulite 2000. Immunoassay system. Software version 2.6 was to be uploaded on systems running 2.5b software.