Lower riskMedical device recall · FDA · Published November 16, 2021
Roche cobas LiatSystem may give false positive flu B results due to high noise levels
Roche recalls a small number of cobas Liat analyzer units with high noise levels causing false positive Influenza B results. Affected units have specific serial numbers and material numbers.
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.
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Contact the company
📍Recalling firmRoche Molecular Systems, Inc.1080 US Highway 202 S · Branchburg, NJ 08876-3733
“Roche cobas LiatSystem may give false positive flu B results due to high noise levels.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61533-roche-cobas-liatsystem-may-give-false-positive-flu-b-results. Based on FDA recall #Z-0828-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0828-2022%22&limit=1).
The FDA announced on Nov. 16, 2021, that Roche Molecular Systems, Inc. is recalling 14 cobas LiatSystem units due to a hazard that increases the probability of false positive Influenza B results. The agency issued recall number Z-0828-2022 for the device.
How to tell if you have it
Brand: Roche
Product: cobas LiatSystem, respiratory virus panel nucleic acid assay system
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.
Context
GovInfoNow's records show Roche Molecular Systems, Inc. has 10 other recalls on record since Oct. 27, 2017. Other recent recalls of similar products include Roche cobas SARS-CoV-2 & Flu A/B tests (Dec. 21, 2022), Roche cobas 5800 PCR device (Sept. 8, 2022), and Roche cobas EGFR Mutation Test v2 (Sept. 3, 2021). Additional recent recalls include Roche cobas pro integrated solutions (Jan. 20, 2026) and Roche Elecsys Anti-TSHR Assay (Nov. 21, 2025).
How to tell if you have this one
Check if your cobas Liat analyzer has the Material Number 07341920190 or the listed serial numbers (16333, 16454, etc.). The device was sold with specific identifiers that can be verified against the provided list.
Brand
Roche
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Identifiers
Verify your cobas Liat analyzer's Material Number and serial numbers against the list provided in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 7 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Colorado, Illinois, Indiana, Kentucky, Michigan, North Carolina, Texas.
Recall timeline
FDA published this recall 5 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0828-2022 (November 16, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0828-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.