Customers have reported an increased number of false positive SARS-CoV-2 results.
Take action
Contact the company
📍Recalling firmRoche Molecular Systems, Inc.1080 US Highway 202 S · Branchburg, NJ 08876-3733
✎ GovInfoNow plain-language explainer
Roche is recalling its cobas SARS-CoV-2 and Influenza A/B tests for the cobas Liat System due to reported false positive results. This could lead to incorrect health decisions if the test shows a positive result when the person is not infected. Read more at govinfonow.com/recall/62083-roche-cobas-sars-cov-2-test-recall-false-positive-risk.
“Roche cobas SARS-CoV-2 Test Recall: False Positive Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62083-roche-cobas-sars-cov-2-test-recall-false-positive-risk. Based on FDA recall #Z-2498-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2498-2021%22&limit=1).
Roche Molecular Systems, Inc. voluntarily recalled the cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System due to false positive results, according to the FDA. The recall was announced on August 4, 2021.
How to tell if you have it
Brand: Roche
Product: cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System
Catalog Number: 09211101190
Lot Code: 10119Z
The hazard
Customers have reported an increased number of false positive SARS-CoV-2 results.
Context
GovInfoNow's records show Roche Molecular Systems, Inc. has had 10 other recalls since October 27, 2017. Other recent recalls include the Roche cobas SARS-CoV-2 & Flu A/B tests recall on December 21, 2022, and the Roche cobas 5800 PCR device recall on September 8, 2022. Similar product recalls include the Roche cobas pro integrated solutions recall on January 20, 2026, and the Meridian Bioscience Revogene C. difficile Test Recall on December 5, 2025.
How to tell if you have this one
Check for the Catalog Number 09211101190 and Lot 10119Z on the test kit. The product is sold for use with the cobas Liat System.
Brand
Roche
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Test Details
Look for Catalog Number 09211101190 and Lot 10119Z on the test kit.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 15 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AR, CA, IL, IN, KS, ME, MI, MN, MO, NY, OR, TN, TX, WA, and WI. The countries of Canada, UK, Austria, Belgium, Croatia, Denmark, Finland, France, Germany, Netherlands,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arkansas, California, Illinois, Indiana, Kansas, Maine, Michigan, Minnesota, Missouri, New York, Oregon, Tennessee, Texas, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 2.6 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-2498-2021 (August 4, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2498-2021 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.