Food, drugs, devices › Data Innovations, LLC
Device recall: IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a
FDA enforcement event 81005 is a device recall by Data Innovations, LLC of South Burlington, VT, initiated 29 Aug 2018 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 5 Feb 2019. Initiation: voluntary: firm initiated. Data Innovations, LLC has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Data Innovations, LLC, South Burlington, VT.
Reason for recall
"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…"
Distribution
"Distributed to OK. Foreign distribution to Argentina, Hong Kong, Malaysia, Thailand, Germany, Jordan, Australia, and Switzerland."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0203-2019 | IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer system (also called a Laboratory Information System [LIS]). | 9 | Class II | Terminated | 31 Oct 2018 |
Context
Other enforcement events for Data Innovations, LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 23 Oct 2014 | JResultNet drivers using ASTM coding language. Calculator/data processing module, for clinical use - Stand-alone softwar | Device | Class II | 1 |
| 15 Aug 2014 | ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package tha | Device | Class II | 1 |
All 3 events for Data Innovations, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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…"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distributed to OK. Foreign distribution to Argentina, Hong Kong, Malaysia, Thailand, Germany, Jordan, Australia, and Switzerland."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 5 Feb 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.