Company:SCC Soft Computer
Date of Enforcement Report 1/11/12
Class ll:
PRODUCT
SoftLab GUI versions: 3.18.1.0-3.18.1.21; 3.19.1.0-3.19.1.25; 3.19.2.0-3.19.2.21; 4.0.0.2; 4.0.1.0-4.0.1.16; 4.0.2.0-4.0.2.10; 4.0.3.0-4.0.3.16; 4.0.4.0-4.0.4.6; and 4.5.0.0-4.5.0.8. Product Usage: 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. Recall # Z-0488-2012
REASON
client reported that results were not flagged correctly. This can occur when a test is ordered in Order Entry, then collected, received, and resulted from the Order Entry results tab in the same session in Order Entry, within a very short time frame. The patient results are accurate, but if the result interpretation flags are missing, an abnormal test result could be overlooked by a physician when reviewing the patient report. Also, if the abnormal flags are missing, the results will not qualify to the Call list..
RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Clearwater, FL, by letter on May 3, 2011. FDA initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
220 units
DISTRIBUTION
Nationwide and Canada
