FDA-Device2017-04-05Class II
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
Data Innovations, LLC
Hazard
Software issue resulting in the results of one patient potentially being associated with another.
Sold states
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.
Affected count
657 units
Manufactured in
120 Kimball Ave Ste 100, South Burlington, VT, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1680-2017Don't want to check this manually?
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