Cl ll SoftLab GUI

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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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