SoftLab version 4.01 ASCII, ASCII Base 3.1.3.0-3.1.3.32, 3.1.4-3.1.4.27, 3.1.6-3.1.6.4, 4.0.0.0-4.0.0.9; LAB/MIC Add-on 4.0.1, 4.0.1.0-4.0.1.13, 4.0.2.0 in 2006. SCC Soft Computer, 5400 Tech Data Drive, Clearwater, FL 33760.
FDA Recall Z-0100-2011 · Posted 2010-10-20
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Recalling FirmSCC Soft Computer
Recall StatusTerminated
Product CodeLNX
Date Initiated2006-08-04
Date Terminated2012-07-16
Product Quantity131
Reason for Recall
For SoftLab version 4.01 ASCII, the qualifying test result does not reach the Call List because the order is locked by either another application, or two Hosparams (HISRR_RBS_sync and Auto_sync_RBS). This creates a lock on the RBS server. The problem was identified in the RBS "C" rule which sends qualifying results to the Call List for SoftLab. All affected clients received the upgrade for Soft
Firm Action
SCC Soft Computer issued a Risk-to-Health notification with Client Notification Verbiage to the affected client using SCC Soft Computer's proprietary Task Management System in June 2006. SCC recommended SoftLab version 4.01 ASCII users change program settings to prevent locking of the RBS server. A software upgrade with corrective patch will be delivered electronically to all clients. Client was asked to acknowledge receipt of the task and grant permission to load the required software.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution: USA in the states of AL, AR, CA, CT, FL, GA, IA, IL, IN, KS, KY, LA, MD, ME, MI, MO, MS, NC, ND, NH, NJ, NY, OH, OK, PA, SD, TN, TX, VA, WA, WI, and WV.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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