SoftMic Versions 4.0.4.7, 4.5.1.3. Version 4.0.4.7 Manufactured 02/03/2010. Version 4.5.1.3 Manufactured 03/18/2010. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760.
This recall has been terminated (originally issued October 19, 2010).
- Company
- Scc Soft Computer
- Recall Initiated
- July 19, 2010
- Posted
- October 19, 2010
- Terminated
- July 16, 2012
- Recall Number
- Z-0088-2011
- Quantity
- 35
- Firm Location
- Clearwater, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Softmic system may delay or omit reporting of clinically significant results including organisms and drug sensitivities. Incomplete culture results may appear complete. SCC Soft Computer is issuing a Correction for SoftMic Versions 4.0.4.7-4.5.1.3 software due to this potential hazard.
Distribution
Worldwide Distribution: USA, including the states of CA, CT, DE, FL, IA, KY, MA, MA, MI, MN, NJ, NY, OH, PA, TX, VA, and WI, and the country of Canada.
Lot / Code Info
Versions 4.0.4.7, 4.5.1.3.
Root Cause
Software design
Action Taken
SCC Soft Computer issued Risk-to-Health notifications to clients on July 19, 2010 via proprietary communication software. Corrective actions will be via programming correction via hot fix (software modification) or such so that Global variable is not used. Clients are asked to acknowledge receipt of this task and update the task with permission to load the required correction.