Recall Z-0344-2011 ยท JQP Calculator/Data Processing Module, For Clinical Use
SCC Soft Computer
SoftLab/Mic ASCII Add-on Versions 4.0.1.14, 4.0.1.15, and 4.0.1.16. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. Version 4.0.1.14 Manufactured & Distributed 12/29/2006. Version 4.0.1.15 Manufactured & Distributed 05/02/2007. Version 4.0.1.16 Manufactured & Distributed 08/22/2008. Used in a medical research or clinical laboratory setting by knowledgeable, trained and experi
| Date | Nov 10, 2010 (initiated Feb 16, 2010) |
| Status | Terminated |
| Reason | When a test is being verified, the wrong (expired) ranges may be associated to that test result, causing an incorrect flag to be posted for that test result. |
| Root cause | Software design |
| Action | Clients were notified via the proprietary communication software on 02/16/2010. The Notification Verbiage identified the affected product and informed clients of the potential hazard, root cause, corrective action, 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 | 31 |
| Distribution | Nationwide Distribution - US and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.