ProVue Instrument Driver for JResultNet — Class II medical device recall Z-2637-2014
Terminated recall by Data Innovations, LLC, reported 2014-09-24, distributed nationwide. Potential issues with the ProVue driver have been identified which may cause data to be misassociated with pat
| Recall number | Z-2637-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Data Innovations, LLC, Fort Myers, FL, United States |
| Recall initiated | 2014-08-15 |
| Classified | 2014-09-12 |
| Reported by FDA | 2014-09-24 |
| Terminated | 2015-03-04 |
| Distributed | Nationwide (US) |
| Quantity | 84 |
Product
ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package that provides connectivity between in-vitro diagnostic instruments (IVDs) and Laboratory Information Systems (LIS) aiding the flow of laboratory information, including test orders and results, specimen information, and patient information.
Reason for recall
Potential issues with the ProVue driver have been identified which may cause data to be misassociated with patient results under a given set of circumstances.
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-2637-2014. 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.