Company:SCC Soft Computer
Date of Enforcement Report 12/8/11
Class ll:
PRODUCT
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. Recall # Z-0261-2012.
REASON
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.
RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Clearwater, FL, via the SCC Soft Computer proprietary Task management system on August 8, 2011. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
255 units
DISTRIBUTION
Nationwide and Canada
