IM Abbott Alinity ci-series accessory driver v8 recalled over fire hazard

Recall date

August 29, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Data Innovations, LLC recalls IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a…

Recall number

Z-0203-2019

FDA classification

Class II

Brand / firm

Data Innovations, LLC

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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]).