Z-1680-2017Class II

JResultNet drivers using ASTM coding language. Calculator/data processing module, for clinical use...

Name: Z-1680-2017 JResultNet drivers using ASTM coding language. Calculator/data processing module, for clinical use...
Creator: Data Innovations, LLC
Published: 2014-10-23
License: https://open.fda.gov/license/

Data Innovations, LLC / initiated 2014-10-23 / Terminated / root cause: software

FDA source

Data Innovations, LLC began a recall of JResultNet drivers using ASTM coding language. Calculator/data processing module, for clinical use - Stand-alone software package that provides connectivity... on 2014-10-23. FDA classified it as Class II and gives the reason as "Software issue resulting in the results of one patient potentially being associated with another". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1680-2017
Classification: Class II
Status: Terminated
Initiated: 2014-10-23
Posted: 2017-02-16
Terminated: 2019-08-21
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
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Software issue resulting in the results of one patient potentially being associated with another.
Root cause tag: software
FDA 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 in commerce: 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.
Product codes and lots: All drive versions were affected.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1680-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1680-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-05	2017-03-24

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)