Recall Z-0088-2011 ยท LNX
SCC Soft Computer
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.
| Date | Oct 19, 2010 (initiated Jul 19, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 35 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.