Z-0828-2022Class II

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

Name: Z-0828-2022 cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
Creator: Roche Molecular Systems, Inc.
Published: 2021-11-16
License: https://open.fda.gov/license/

Roche Molecular Systems Inc / initiated 2021-11-16 / Open, Classified / root cause: manufacturing process

FDA source

Roche Molecular Systems, Inc. began a recall of cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190 on 2021-11-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0828-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-11-16
Posted: 2022-03-28
Recalling firm: Roche Molecular Systems Inc
Product: cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
Product code: OOI Real Time Nucleic Acid Amplification System
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 14 units
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 codes and lots: UDI: 07613336100097; Serial Numbers: 16333, 16454, 16688, 16695, 16871, 16914, 17048, 17266, 19924, 18094, 18323, 18357, 17116, 17086

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0828-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0828-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-06	2022-03-28

Product code OOI

K111387Class IILiat (Tm) Influenza a / B Assay, Liat (Tm) AnalyzerIquum, Inc. / cleared 2011-08-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)