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]).
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAHIGHER HARVEST by H-E-B brand; Dairy Free Coconut Based YOGURT; STRAWBERRY; YOGURT ALTERNATIVE; NET WT 5.3 OZ; INGREDIENTS: COCONUT MILK (WATER, COCONUT CREAM, MODIFIED TAPIOCA STARCH), STRAWBERRIES, CANE SUGAR, WATER, STARCH, NATURAL FLAVOR, FRUITS AND VEGETABLE JUICE (FOR COLOR) LOCUST BEAN GUM...2025-12-17
- CPSCRomorgniz Fabric 12- and 13-Drawer Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment; Violates Mandatory Standard for Clothing Storage Units; Sold on Amazon by Romorgniz2025-11-20
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