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Class 2 Device Recall SoftLab GUI Version 4.0.1.0 4.0.1.16, 4.0.2.0 4.0.2.10, 4.0.3.0 4.0.3.13, and 4.0.4.0 4.0.4. |
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| Date Initiated by Firm |
April 01, 2009 |
| Date Posted |
November 16, 2010 |
| Recall Status1 |
Terminated 3 on August 07, 2013 |
| Recall Number |
Z-0365-2011 |
| Recall Event ID |
56867 |
| Product Classification |
Calculator/Data Processing Module for Clinical Use - Product Code JQP
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| Product |
SoftLab GUI Version 4.0.1.0 - 4.0.1.16, 4.0.2.0 - 4.0.2.10, 4.0.3.0 - 4.0.3.13, and 4.0.4.0 - 4.0.4.5.
SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760.
Manufacture/Distribution Dates:
4.0.1.0 - 08/06/04,
4.0.1.4 - 10/18/04,
4.0.1.5 - 01/18/04,
4.0.1.6 - 12/15/04,
4.0.1.7 - 01/10/05,
4.0.1.8 - 03/29/05,
4.0.1.9 - 05/06/05,
4.0.1.13 - 01/25/06,
4.0.1.14 - 03/26/07
4.0.1.15 - 05/02/07,
4.0.1.16 - 08/22/08,
4.0.2.0 - 04/08/05,
4.0.2.1 - 08/13/08,
4.0.2.2 - 06/06/05,
4.0.2.3 - 09/19/05,
4.0.2.4 - 09/19/05,
4.0.2.5 - 09/19/05,
4.0.2.7 - 02/13/06,
4.0.2.8 - 12/12/06,
4.0.2.9 - 02/20/08,
04.2.10 - 08/13/08,
4.0.3.2 - 05/17/06,
4.0.3.3 - 09/18/06,
4.0.3.4 - 09/27/06,
4.0.3.5 - 11/29/06,
4.0.3.6 - 06/22/07,
4.0.3.7 - 03/28/07,
4.0.3.8 - 06/22/07,
4.0.3.9 - 08/03/07,
4.0.3.10 - 08/24/07,
4.0.3.11 - 09/24/07,
4.0.3.12 - 03/07/08,
4.0.3.13 - 06/13/08,
4.0.4.2 - 02/22/08,
4.0.4.3 - 05/22/08,
4.0.4.4 - 07/28/08,
4.0.4.5 - 05/04/09.
Intends to provide clients with an interface that links all clinical laboratory departments throughout the enterprise.
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| Code Information |
Versions: 4.0.1.0 - 4.0.1.16; 4.0.2.0 - 4.0.2.10; 4.0.3.0 - 4.0.3.13; and 4.0.4.0 - 4.0.4.5. |
Recalling Firm/
Manufacturer |
SCC Soft Computer
5400 Tech Data Drive
Clearwater FL 33760
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| For Additional Information Contact |
727-789-0100
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Manufacturer Reason
for Recall |
Clients using Patient Maintenance to perform Moves of Stays may send the wrong billing number during an ADT update to SoftWeb, SoftPath or SoftMedia. The wrong billing number can come from a different patient in Order Entry. Only Moves of Stays are affected.
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FDA Determined
Cause 2 |
Software design |
| Action |
Clients were notified via the proprietary communication software on 06/01/2009. This is a MANDATORY CORRECTION. The Risk-To-Health Notification Task gives the background on the issue, the potential hazard, root cause, corrective action, alternative working solution, and requested action. Clients were instructed to acknowledge receipt of the notification. If the client wishes to receive the correction, they should document a request to load the software. |
| Quantity in Commerce |
49 |
| Distribution |
Nationwide Distribution |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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