Data Innovations Recalls Abbott Alinity ci-series Software Driver
Data Innovations is recalling a software driver for Abbott Alinity ci-series instruments that fails to process quality control results, potentially delaying or causing incorrect patient treatment.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
Data Innovations, LLC is recalling the IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product. This software is designed to receive information from hospital computer systems, specifically Laboratory Information Systems (LIS). The recall involves 9 units of the software.
The recall is due to a driver malfunction where quality control (QC) results are not processed when the "Hold Results Until Complete" option is enabled. Although the communication trace shows the sample being transmitted, no information is logged in the Specimen Event Log. This malfunction creates a potential for harm because downstream auto-verification rules may misfire based on missing QC results, which could lead to a delay in, or incorrect, patient treatment. Additionally, QC results are not available for evaluation by the laboratory. The source text states that there have been no reported instances of patient harm from this malfunction.
The affected software was distributed to Oklahoma in the United States and to Argentina, Hong Kong, Malaysia, Thailand, Germany, Jordan, Australia, and Switzerland. Users of this software should contact Data Innovations, LLC for further instructions on how to address the malfunction.
The recalled product
- 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]).
- Manufacturer
- Data Innovations, LLC
- Category
- Medical Device — Software
- Affected units
- 9
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- accessory driver version number 8.00.0001
Distribution
Distributed in 1 state:
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