FDA Recall Terminated

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.

Recall: Z-0100-2011 · Initiated August 4, 2006

Recall

Recall Number
Z-0100-2011
Event Number
56283
Firm
SCC Soft Computer
FEI Number
1000307651
Product Code
LNX
Status
Terminated
Root Cause
Software design
Initiated
August 4, 2006
Posted
October 20, 2010
Terminated
July 16, 2012
Address
5400 Tech Data Drive, Clearwater, FL, 33760

Description

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.

Reason

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

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.

Distribution

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.

Quantity

131