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# Roche Covid/Influenza Assay False Positives: FDA
- URL: https://www.fdaweb.com/roche-covid-influenza-assay-false-positives-fda/
- Published: 2021-03-12T12:00:00.000Z
- Updated: 2026-09-14T16:50:38.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5148870

FDA is alerting health care providers and laboratory staff about false positive results which can occur with the Roche Molecular Systems’ cobas SARS-CoV-2 and Influenza A/B Nucleic Acid Test that is used on the cobas Liat System. The false positive results might be related to the assay tubes that may sporadically leak, causing an obstructed optical path in the Liat analyzer, producing abnormal PCR growth curves, according to the [alert](https://www.fda.gov/medical-devices/letters-health-care-providers/potential-false-results-roche-molecular-systems-inc-cobas-sars-cov-2-influenza-test-use-cobas-liat?ref=fdaweb.com). They also might be caused by abnormal polymerase chain reaction (PCR) cycling in the reaction tubes that may also produce abnormal PCR growth curves and leading to erroneous results.