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.
This recall has been terminated (originally issued January 11, 2012).
- Company
- Scc Soft Computer
- Recall Initiated
- August 25, 2011
- Posted
- January 11, 2012
- Terminated
- October 3, 2014
- Recall Number
- Z-0466-2012
- Quantity
- 144
- Firm Location
- Clearwater, FL
- Official Source
- View on FDA website ↗
Reason for Recall
On 08/25/2011, SCC Soft Computer initiated a correction on the following SoftMic GUI versions: 4.0.3.0-4.0.3.15, 4.0.4.1-4.0.4.7. For clients using SoftMic Result Entry, 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
Distribution
Worldwide Distribution -- USA (nationwide) and Canada.
Lot / Code Info
SoftMic GUI versions: 4.0.3.0-4.0.3.15, 4.0.4.1-4.0.4.7.
Root Cause
Software design
Action Taken
SCC Soft Computer initiated a Field Correction dated August 25, 2011. to all affected customers. Customers with the affected software have been notified and are scheduling receipt of the hot fix.. Further questions call (727) 789-0100.