Z-1680-2017 Class II Terminated
FDA device recall Z-1680-2017 was initiated by Data Innovations, LLC on October 23, 2014 and is designated Class II. Reason for recall: Software issue resulting in the results of one patient potentially being associated with another. The recall status is terminated (terminated August 21, 2019). Affected quantity: 657 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 5, 2017
- Initiation Date
- October 23, 2014
- Termination Date
- August 21, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 657 units
Product Description
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
Reason for Recall
Software issue resulting in the results of one patient potentially being associated with another.
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.
Code Information
All drive versions were affected.