Class II — Potential Health Hazard

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

cobas LiatSystem Recalled by Roche Molecular Systems, Inc. Due to Roche has identified a small number of cobas...

Date: November 16, 2021
Company: Roche Molecular Systems, 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 Roche Molecular Systems, Inc. directly.

Affected Products

cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190

Quantity: 14 units

Why Was This Recalled?

Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels (background signal) originating from the amber detector (used for Influenza B detection). This noise increases the probability of false positive Influenza B results.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Roche Molecular Systems, Inc.

Roche Molecular Systems, Inc. has 42 total recalls tracked by RecallDetector.

Related Recalls

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