Recall Z-1680-2017 ยท JQP Calculator/Data Processing Module, For Clinical Use
Data Innovations, LLC
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
| Date | Feb 16, 2017 (initiated Oct 23, 2014) |
| Status | Terminated |
| Reason | Software issue resulting in the results of one patient potentially being associated with another. |
| Root cause | Software design |
| Action | Data Innovations, LLC contacted consignees by phone, email, and post. Recall notifications were sent out on November 3, 2014. Consignees were provided instructions on how to reconfigure the drive to work around the issue. If consignees were unable to perform the work around, Customer Support is able to service the units. In order to request this service, consignees were to call 239-931-6004, 802-658-1955, or 800-332-0499. Attached to the recall notification was a response form that is to be faxed to 802-658-2782. Consignees with and without affected drives are to complete this response form. |
| Quantity | 657 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.