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.
This recall has been terminated (originally issued February 2, 2015).
- Company
- Scc Soft Computer
- Recall Initiated
- May 20, 2014
- Posted
- February 2, 2015
- Terminated
- May 16, 2016
- Recall Number
- Z-1038-2015
- Quantity
- 48
- Firm Location
- Clearwater, FL
- Official Source
- View on FDA website ↗
Reason for Recall
The interface fails to send abnormal flags for Reference Lab test results.
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.
Lot / Code Info
4.0.7.0: released 12/13/13 - present 4.0.7.1: released 02/28/14 - present
Root Cause
Device Design
Action Taken
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."