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.
FDA Recall Z-0088-2011 · Posted 2010-10-19
Recalling FirmSCC Soft Computer
Recall StatusTerminated
Product CodeLNX
Date Initiated2010-07-19
Date Terminated2012-07-16
Product Quantity35
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.