SoftID.NET versions 2.0.0.6 - 2.0.0.19. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. SoftID.NET is to be used in a medical or clinical laboratory setting by knowledgeable, trained, and experienced professionals. SoftID.NET supports bedside collection of patient specimens used in diagnostic testing. This product is integrated with Soft Computer's SoftLab, SoftScape and can also interface with all other SCC laboratory systems and Hospital Information Systems (HIS).
This recall has been terminated (originally issued November 15, 2010).
- Company
- Scc Soft Computer
- Recall Initiated
- August 28, 2009
- Posted
- November 15, 2010
- Terminated
- November 16, 2011
- Recall Number
- Z-0360-2011
- Quantity
- 41
- Firm Location
- Clearwater, FL
- Official Source
- View on FDA website ↗
Reason for Recall
SCC Soft Computer issued a Correction for SoftID.NET versions 2.0.0.6 - 2.0.0.19. When using the Cancel functionality, if the collection list refreshes during the transaction and changes the position of the patient on the list, the wrong patient order can be cancelled. All affected clients have been notified.
Distribution
Nationwide distribution: AR, CA, FL, IL, IN, KS,LA, MA, MI, MN, MO, NC, ND,NH, NJ, NY, OH, PA, RI, TN, TX, VA and WI.
Lot / Code Info
Versions: SoftID.NET 2.0.0.6 - 4/3/2007, SoftID.NET 2.0.0.7 - 6/21/2007, SoftID.NET 2.0.0.8 - 8/29/2007, SoftID.NET 2.0.0.9 - 10/01/2007, SoftID.NET 2.0.0.10 - 10/25/2007, SoftID.NET 2.0.0.11 - 11/07/2007, SoftID.NET 2.0.0.12 - 2/08/2008, SoftID.NET 2.0.0.13 - 5/13/2008, SoftID.NET 2.0.0.14 - 6/12/2008, SoftID.NET 2.0.0.15 - 8/15/2008, SoftID.NET 2.0.0.16 - 10/15/2008, SoftID.NET 2.0.0.17 - 12/15/2008, SoftID.NET 2.0.0.18 - 2/02/2009, SoftID.NET 2.0.0.19 - 5/18/2009.
Root Cause
Software design
Action Taken
SCC Soft Computer notified Customers on August 28, 2009, via the proprietary communication software entitled "Risk-to-Health Notification Task Verbiage" dated August 17, 2009. The notification described the product, problem and action to be taken by customer. The customers were instructed to acknowledge receipt of the notification; document a request to load the software, if they wish to receive the correction; document that the Alternative Working Solution will be used by the customers facility until the correction has been taken live. If you have any questions, contact (727) 789-0100.