FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-1680-2017
- Recalling firm
- Data Innovations, LLC
- 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
- Status
- Terminated
- Initiated
- 2014-10-23
- Posted
- 2017-02-16
- Terminated
- 2019-08-21
- 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. For questions regarding this recall call 239-931-6004.
- 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.
- Lot, serial or model codes
- All drive versions were affected.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- Firm FEI
- 3001451449
- Firm city
- South Burlington
- Firm state
- VT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28