Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Alinity ci-series System Control Module (SCM) Recalled by Abbott Laboratories Due to Abbott Laboratories is recalling their Alinity ci-series System...

Date: November 13, 2025
Company: Abbott Laboratories
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Abbott Laboratories directly.

Affected Products

Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20

Quantity: 11653

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Abbott Laboratories

Abbott Laboratories has 124 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report