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 m System Recalled by Abbott Molecular, Inc. Due to There is an issue with the installation of...

Date: December 6, 2021
Company: Abbott Molecular, Inc.
Status: Terminated
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 Molecular, Inc. directly.

Affected Products

Alinity m System, Part No. 08N53-002

Quantity: 74 devices

Why Was This Recalled?

There is an issue with the installation of updated camera firmware on the system.

Where Was This Sold?

This product was distributed to 16 states: CA, GA, IL, KY, MD, MI, MN, MS, NH, NJ, NY, RI, SD, TX, WI, DC

Affected (16 states)Not affected

About Abbott Molecular, Inc.

Abbott Molecular, Inc. has 30 total recalls tracked by RecallDetector.

Related Recalls

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