IM Abbott Alinity ci-series — Class II medical device recall Z-0203-2019
Terminated recall by Data Innovations, LLC, reported 2018-10-31. Quality control results are not processed for Abbott Diagnostics Alinity ci series (abdicqii) instrument. This
| Recall number | Z-0203-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Data Innovations, LLC, South Burlington, VT, United States |
| Recall initiated | 2018-08-29 |
| Classified | 2018-10-22 |
| Reported by FDA | 2018-10-31 |
| Terminated | 2019-02-05 |
| Countries outside the US | AR, AU, CH, DE, HK, JO, MY, TH |
| Quantity | 9 |
| Reason classes | device malfunction |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0203-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.