Z-1680-2017 Class II Terminated

Recalled by Data Innovations, LLC — South Burlington, VT

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.