Class II — Data Innovations, LLC
| Recalling firm | DATA INNOVATIONS LLC |
|---|---|
| Registered facility | DATA INNOVATIONS, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 84 |
| Distribution | Nationwide Distribution including AL, AZ, CA, CT, DC, FL, GA, IN, LA, MI, MO, NC, NH, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, and WA. |
| Initiated | 2014-08-15 |
| Classified | 2014-09-12 |
| Terminated | 2015-03-04 |
| Recall number | Z-2637-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Data Innovations, LLC (Z-2637-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69086/
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