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Data Innovations, LLC recalls JResultNet drivers using ASTM coding language. Calculator/data processing module, for clinical use - Stand-alone softwa
Recalled April 5, 2017 · FDA recall Z-1680-2017 · Data Innovations
Hazard
Software issue resulting in the results of one patient potentially being associated with another. · FDA Class II
Units
657 units
Sold at
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.
Description
Software issue resulting in the results of one patient potentially being associated with another.
Product
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
Manufacturer(s)
Data Innovations, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →