Device 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
Z-1680-2017
Product summary
- Event
- Event 76036
- Status
- Terminated
- Classification
- Class II
- Quantity
- 657 units
- Official record key
device-enforcement:Z-1680-2017
Official wording
Reason: Software issue resulting in the results of one patient potentially being associated with another.
Code information: All drive versions were affected.
Distribution pattern: 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.
Derived failure modes
-
Device software or design
Software issue