FDA-Device2015-02-11Class II
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.
SCC Soft Computer
Hazard
The interface fails to send abnormal flags for Reference Lab test results.
Sold states
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.
Affected count
48
Manufactured in
5400 Tech Data Drive, N/A, Clearwater, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1038-2015Don't want to check this manually?
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