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 HBV AMP Kit (US and CE) Recalled by Abbott Molecular, Inc. Due to There is a potential for misquantitation high results...

Date: March 4, 2022
Company: Abbott Molecular, Inc.
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 Molecular, Inc. directly.

Affected Products

Alinity m HBV AMP Kit (US and CE)

Quantity: 4966 kits, updated 101/17/2023

Why Was This Recalled?

There is a potential for misquantitation high results for negative samples.

Where Was This Sold?

This product was distributed to 14 states: AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, VA

Affected (14 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