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 SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System Recalled by Roche Molecular Systems, Inc. Due to Customers have reported an increased number of false...

Date: August 4, 2021
Company: Roche Molecular Systems, 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 Roche Molecular Systems, Inc. directly.

Affected Products

cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190

Quantity: 211 kits (US); 3073 kits (OUS)

Why Was This Recalled?

Customers have reported an increased number of false positive SARS-CoV-2 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