Roche recalls cobas Liat Analyzer respiratory virus panel due to potential false positive results for SARS-CoV-2, Influenza A, and B tests. Affected units may show abnormal PCR growth curves.
Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under emergency use authorization on the cobas Liat analyzer, showed abnormal PCR growth curves
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📍Recalling firmRoche Molecular Systems, Inc.1080 US Highway 202 S · Branchburg, NJ 08876-3733
✎ GovInfoNow plain-language explainer
Roche is recalling its cobas Liat Analyzer respiratory virus panel nucleic acid assay system because it can produce false positive results for SARS-CoV-2, Influenza A, and Influenza B tests. This means test results could be inaccurate, potentially leading to incorrect health decisions. Read more at govinfonow.com/recall/62909-roche-cobas-liat-analyzer-false-positive-results-risk-inaccurate-test.
“Roche cobas Liat Analyzer: False positive results risk inaccurate test results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62909-roche-cobas-liat-analyzer-false-positive-results-risk-inaccurate-test. Based on FDA recall #Z-1414-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1414-2021%22&limit=1).
Roche Molecular Systems, Inc. voluntarily recalled the cobas Liat Analyzer respiratory virus panel nucleic acid assay system (Catalog Number 07341920190) on March 25, 2021, according to the FDA. The device may produce invalid or false positive results for SARS-CoV-2 and Influenza A/B targets due to abnormal PCR growth curves.
The recall addresses invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay on the cobas Liat analyzer. The record states these errors are caused by abnormal PCR growth curves.
Context
GovInfoNow's records show Roche Molecular Systems, Inc. has had 10 other recalls since October 27, 2017. Recent similar recalls include the Roche Influenza A/B & RSV Test Recall on December 21, 2022, and the Roche cobas 5800 PCR device recall on September 8, 2022. Other recent recalls of similar products include the Roche cobas pro integrated solutions recall (January 20, 2026), the Roche Elecsys Anti-TSHR Assay Recall (November 21, 2025), and the BioFire Respiratory Panel 2.1 recall (June 24, 2026).
How to tell if you have this one
Check for the catalog number 07341920190 on the cobas Liat Analyzer. All units with this specific catalog number are affected.
Brand
Roche
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Nationwide WorldWide
Recall number
Product, codes & lots
Quantity
Z-1413-2021
cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Catalog Number: 09211101190; All lot numbers
US: 143,823 kits Ex-US: 57,219 kits
Z-1414-2021
cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190; All serial ID numbers
US: 5,430 units ; OUS 1528 units
Based on the official FDA remedy
What to do — step by step
Check Device Catalog Number
Look for the catalog number 07341920190 on the cobas Liat Analyzer.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Nationwide WorldWide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 27 days 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-1414-2021 (March 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1414-2021 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.