Recall Z-1038-2015 ยท JQP Calculator/Data Processing Module, For Clinical Use
SCC Soft Computer
SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research or clinical laboratory.
| Date | Feb 2, 2015 (initiated May 20, 2014) |
| Status | Terminated |
| Reason | The interface fails to send abnormal flags for Reference Lab test results. |
| Root cause | Device Design |
| Action | The firm sent out 2 CORRECTION COMMUNICATIONS informing consignees of functionality in release of 4.0.7 HIS Add-on interfaces which SCC has designated to be a potential patient Risk-to-Health issue. Further the corrective action indicated HIS releases 4.0.7.2 and higher will be corrected. Hot Fixes have been developed for HIS Add-on patches 4.0.7.0 and 4.0.7.1. Lastly the communication requests that the user "please acknowledge receipt of this task and grant permission to load the mandatory hot fix(es). Thank you." |
| Quantity | 48 |
| Distribution | Distributed US (nationwide) in the states of OH, GA, NJ, WI, FL, NH, IL, NY, IN, CA, AL, VA, MO, MI, KY, MA, PA, CO, ME, TN, WA, MN, SD, LA, NC, and NV 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.