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
On 08/08/2011 scc soft computer, clearwater, fl initiated a correction on following softlab used with: sa base 3.1.4.X, 3.1.6.X and sa labmic 4.0.0.X, 4.0.1.X, 4.0.2.X, 4.0.3.X, 4.0.4.X. a client reported a flagging error where the result was flagged as critical in the instrument menu but the printed report did not show the corresponding flag. all affected clients were notified of the issue on 0.
조치
SCC Soft Computer notified all affected customers on August 8, 2011, of the recall via the SCC Soft Computer proprietary Task management system to manage client communication. Clients use this tool to log in requests for services and receive and provide updates to any issue.
Each client user has a unique password and every action is date and time-stamped. Each Task has a unique identifier and a full audit trail.
SCC recommended to the customer until Live on the correction avoid making edits in the instrument menu.
For further questions please call (727) 789-0100.
Worldwide Distribution - USA ( nationwide) and Canada.
제품 설명
Software: SA BASE 3.1.4.x, 3.1.6.x and SA LabMic 4.0.0.x, 4.0.1.x, 4.0.2.x, 4.0.3.x, 4.0.4.x. || SoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and reporting laboratory data.