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
Calculator/data processing module, for clinical use - Product Code JQP
원인
The interface fails to send abnormal flags for reference lab test results.
조치
The firm sent out 2 CORRECTION COMMUNICATIONS informing consignees of functionality in release of 4.0.7 HIS Add-on interfaces which SCC has designated to be a potential patient Risk-to-Health issue. Further the corrective action indicated HIS releases 4.0.7.2 and higher will be corrected. Hot Fixes have been developed for HIS Add-on patches 4.0.7.0 and 4.0.7.1. Lastly the communication requests that the user "please acknowledge receipt of this task and grant permission to load the mandatory hot fix(es). Thank you."
Distributed US (nationwide) in the states of OH, GA, NJ, WI, FL, NH, IL, NY, IN, CA, AL, VA, MO, MI, KY, MA, PA, CO, ME, TN, WA, MN, SD, LA, NC, and NV and the country of Canada.
제품 설명
SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 || SoftLab is a laboratory information system to be used in a medical research or clinical laboratory.