Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Recalled by Abbott Molecular, Inc. Due to There is a potential for false positive results.

Date: September 2, 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 Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic

Quantity: 5855 units

Why Was This Recalled?

There is a potential for false positive results.

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