# FDA recall Z-0203-2019

> **Data Innovations, LLC** · Class II · device recall initiated 2018-08-29.

## Product

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]).

## 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 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.

## Distribution

Distributed to OK. Foreign distribution to Argentina, Hong Kong, Malaysia, Thailand, Germany, Jordan, Australia, and Switzerland.

## Key facts

- **Recall number:** Z-0203-2019
- **Recalling firm:** Data Innovations, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-29
- **Report date:** 2018-10-31
- **Termination date:** 2019-02-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** South Burlington, VT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0203-2019

## Citation

> AI Analytics. FDA recall Z-0203-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0203-2019. Source: US FDA. Licensed CC0.

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