Recall Z-0360-2011 ยท LNX
SCC Soft Computer
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
| Date | Nov 15, 2010 (initiated Aug 28, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 41 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.