Data Foundry

Medical device recalls 2017

JResultNet drivers using ASTM coding language — Class II medical device recall Z-1680-2017

Terminated recall by Data Innovations, LLC, reported 2017-04-05, distributed nationwide. Software issue resulting in the results of one patient potentially being associated with another.

Recall numberZ-1680-2017
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmData Innovations, LLC, South Burlington, VT, United States
Recall initiated2014-10-23
Classified2017-03-24
Reported by FDA2017-04-05
Terminated2019-08-21
DistributedNationwide (US)
Quantity657 units
Reason classessoftware

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

Reason for recall

Software issue resulting in the results of one patient potentially being associated with another.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1680-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.