Soft Computer Consultants, Inc. recalls Softbank software Product Usage: Decision support software for transfusion service. It keeps track of inventory from ou…

Recall date

October 6, 2016

Source

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

Recall number

Z-1098-2017

FDA classification

Class II

Brand / firm

Soft Computer Consultants, Inc.

Sold / distributed

Worldwide Distribution - US Nationwide Distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WA, WI, WV, and the countries of Hawaii and Puerto Rico Canada & Jamaica

Why it was recalled

Software error. Potential for incorrect 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

Softbank software Product Usage: Decision support software for transfusion service. It keeps track of inventory from outside sources, multi-site inventory control, records of testing of units, and allows for record keeping for transfusion preparation.