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 researc…

Recall date

May 20, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1038-2015

FDA classification

Class II

Brand / firm

SCC Soft Computer

Sold / distributed

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.

Why it was recalled

The interface fails to send abnormal flags for Reference Lab test results.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.