Recall Z-0488-2012 ยท JQP Calculator/Data Processing Module, For Clinical Use
SCC Soft Computer
SoftLab GUI versions: 3.18.1.0-3.18.1.21; 3.19.1.0-3.19.1.25; 3.19.2.0-3.19.2.21; 4.0.0.2; 4.0.1.0-4.0.1.16; 4.0.2.0-4.0.2.10; 4.0.3.0-4.0.3.16; 4.0.4.0-4.0.4.6; and 4.5.0.0-4.5.0.8. Product Usage: SoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-proces
| Date | Jan 11, 2012 (initiated May 3, 2011) |
| Status | Terminated |
| Reason | On 05/03/2011, SCC Soft Computer, Clearwater, FL, initiated a correction on the following SoftLab GUI versions: 3.18.1.0-3.18.1.21; 3.19.1.0-3.19.1.25; 3.19.2.0-3.19.2.21; 4.0.0.2; 4.0.1.0-4.0.1.16; 4.0.2.0-4.0.2.10; 4.0.3.0-4.0.3.16; 4.0.4.0-4.0.4.6; and 4.5.0.0-4.5.0.8. A client reported that results were not flagged correctly. This can occur when a test is ordered in Order Entry, then collected |
| Root cause | Software design |
| Action | SCC Soft Computer sent a "CORRECTION COMMUNICATION" notification letter to all affected customers. The letter describes the product, Risk-to-Health notification task, potential hazard, and corrective action. The customers were asked to acknowledge receipt of the task and grant permission for SCC to make the required and recommended changes. For any questions, call (727) 789-0100. |
| Quantity | 220 |
| Distribution | Worldwide Distribution - USA (nationwide) and the country of: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.