Company:SCC Soft Computer.
Date of Enforcement Report 1/4/12
Class ll:
PRODUCT
SoftMic GUI versions: 4.0.3.0-4.0.3.15, 4.0.4.1-4.0.4.7. SoftMic is a laboratory information system to be used in medical research, clinical, and public health laboratories by knowledgeable, trained, and experienced personnel. SoftMic enables the user to handle data processing and laboratory activities for microbiology and serology testing, for the purpose of storing, managing, querying, and reporting laboratory data. Recall # Z-0466-2012
REASON
When a certain series of keystrokes on the test grid are performed while entering results and statusing a test, the test status may not be maintained upon saving. The status may be removed or copied from another test on the order upon saving.
RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Clearwater, FL, by a Field Correction dated August 25, 2011. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
units
DISTRIBUTION
Nationwide and Canada
