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SCC Soft Computer recalls 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 resea
Recalled February 11, 2015 · FDA recall Z-1038-2015 · SCC Soft Computer
Hazard
The interface fails to send abnormal flags for Reference Lab test results. · FDA Class II
Units
48
Sold at
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.
Description
The interface fails to send abnormal flags for Reference Lab test results.
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.
Manufacturer(s)
SCC Soft Computer
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →