Abbott Laboratories: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations.

Tags

FDA recall, medical device, class 1, Clinical Chemistry, Software design, Open, Classified

Related exam domains

CISSP 3: Security Architecture and Engineering; CISSP 6: Security Assessment and Testing; CISSP 8: Software Development Security; CISM 3: Information Security Program

Source record id

Z-0961-2026

First seen by InfoSec Signals

Sep 23, 2026

Source: openFDA device recalls, U.S. Food and Drug Administration · about this source · more from it

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