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 Integrated Reaction Units (IRU) Recalled by Abbott Molecular, Inc. Due to There is potential for the Reaction Vessels (RVs)...

Date: February 11, 2022
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 Integrated Reaction Units (IRU)

Quantity: 3063 kits

Why Was This Recalled?

There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 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