cobas LiatSystem, respiratory virus panel nucleic acid… recallZ-0828-2022 · Roche Molecular Systems, Inc. · initiated Nov 16, 2021

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Roche Molecular Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

A Customer Bulletin dated 11/16/21 was sent to customers. Analyzer Return Procedure Our records indicate that you have one of the affected cobas Liat analyzers listed on the previous page. Because of the issue, Roche will send you a new cobas Liat analyzer. Please return your affected analyzer immediately to Roche for investigation by following the steps below: 1. A representative from the Roche Support Network Customer Support Center will contact you to initiate analyzer replacement and confirm shipping information. 2. When you receive the new cobas Liat analyzer from Roche, remove the new analyzer and FedEx shipping label from the box. 3. Place the affected analyzer in the box and seal it using packing tape. 4. Affix the FedEx postage paid shipping label to the outside of the box. 5. Take the box containing the affected analyzer to an appropriate FedEx location for return shipping at no charge to you. Actions Required " Follow the steps in the Analyzer Return Procedure section above. " File this Customer Bulletin for future reference. Please contact the Roche Support Network Customer Support Center at 1-800-800-5973 if you have questions about the information in this Customer Bulletin.

Recall details

Recall number: Z-0828-2022
Status: Open, Classified
Initiated by the company: Nov 16, 2021
Recalling firm: Roche Molecular Systems, Inc.
Quantity: 14 units
Product code: OOI
FDA submissions: K111387
Distribution: Worldwide distribution - US Nationwide distribution in the states of CO, IL, IN, KY, MI, NC, and TX. The countries of Cyprus, Spain, and Hong Kong.

Product description

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

Code information (models, lots, serial numbers)

UDI: 07613336100097; Serial Numbers: 16333, 16454, 16688, 16695, 16871, 16914, 17048, 17266, 19924, 18094, 18323, 18357, 17116, 17086

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

cobas Liat Analyzer 07341920190
Roche Molecular Systems, Inc. · real time Nucleic acid amplification system
1 recall4 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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