Data Innovations, LLC recalls JResultNet drivers using ASTM coding language. Calculator/data processing module, for clinical use - Stand-alone softwa…

Recall date

October 23, 2014

Source

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

Recall number

Z-1680-2017

FDA classification

Class II

Brand / firm

Data Innovations, LLC

Sold / distributed

Nationwide Distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, & DC.

Why it was recalled

Software issue resulting in the results of one patient potentially being associated with another.

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

What was recalled

JResultNet drivers using ASTM coding language. Calculator/data processing module, for clinical use - Stand-alone software package that provides connectivity between in-vitro diagnostic instruments and laboratory information's systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information