Device product
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.
Z-1038-2015
Product summary
- Event
- Event 70021
- Status
- Terminated
- Classification
- Class II
- Quantity
- 48
- Official record key
device-enforcement:Z-1038-2015
Official wording
Reason: The interface fails to send abnormal flags for Reference Lab test results.
Code information: 4.0.7.0: released 12/13/13 - present 4.0.7.1: released 02/28/14 - present
Distribution pattern: 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.
Derived failure modes
-
Unknown
The interface fails to send abnormal flags for Reference Lab test results.