Is this your brand? Sign in to claim ownership.
Sign in to claim this brandDATA INNOVATIONS, LLC
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 463 Mountain View Dr Ste 305, Colchester, VT, 05446
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3001451449
- DUNS Number
- —
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bloodstream Software | 1.1 | FDA UDI | Class II | Active |
| Bloodstream Software | 1.2 | FDA UDI | Class II | Active |
| Instrument Manager | 816 | FDA UDI | Class II | Active |
| Bloodstream Software | 1.0 | FDA UDI | Class II | Active |
| Instrument Manager | 8141101 | FDA UDI | Class II | Unknown |
| Instrument Manager | 817 | FDA UDI | Class II | Active |
| Instrument Manager | 900 | FDA UDI | Class II | Active |
| Instrument Manager | 8150011 | FDA UDI | Class II | Unknown |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (8)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Aug 29, 2018 | Z-0203-2019 | — | terminated | Quality control results are not processed for Abbott Diagnostics Alinity ci series (abdicqii) instrument. This has been determined to be a driver malfunction. When an instrument transmits results from a quality control (QC) sample ID ("Q^Control" in SPM segment), and the option Hold Results Until Complete is enabled, the results do not parse into IM. The communication Trace shows the sample being transmitted, but no information is logged in the Specimen Event Log (SEL). There is a potential for harm if QC results are not processed, downstream auto verification rules may misfire based on missing QC results leading to a delay in, or incorrect treatment. QC results will not be available for evaluation by the lab. There have been no reported instances of patient harm from this malfunction. |
| Oct 23, 2014 | Z-1680-2017 | — | terminated | Software issue resulting in the results of one patient potentially being associated with another. |
| Aug 15, 2014 | Z-2637-2014 | — | terminated | 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. |
| Nov 6, 2013 | Z-0571-2014 | — | terminated | When connected to the Sysmex UF-100, the Instrument Manager driver sysu100i driver software versions 7.00.0001, 7.00.0002, 7.00.0003, 7.00.0004, 7.00.0005, 8.00.0001, 8.00.0002, 8.00.0003, and 8.00.0004, and is configured with option "Strip Zeros from Result" set to "Yes" may result in sample error |
| May 11, 2009 | Z-0083-2012 | — | terminated | The "previous result" retrieved from the Specimen Management Database may not be the most recent "previous result". |
| Nov 3, 2006 | Z-0223-2007 | — | terminated | Software of modular driver may incorrectly report patient results as Quality Control Results |
| Nov 3, 2006 | Z-0224-2007 | — | terminated | Software of modular driver may incorrectly report patient results as Quality Control Results |
| Aug 10, 2006 | Z-0167-2007 | — | terminated | Patient results may be associated with an incorrect specimen |