--- title: "Roche Molecular Systems, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Roche Molecular Systems, Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/roche-molecular-systems-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Roche Molecular Systems, Inc. recall records **4** reported ongoing 5 records in this archive. Latest source date Dec 21, 2022. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Dec 21, 2022 FDA device enforcement ### [cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190](https://isitonrecall.com/recall/fda-device-z-1104-2023-cobas-sars-cov-2-influenza-a-b-qualitative-assay-for-use-on-the-cobas-6800-8800-systems-material-num/) The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress, and delays to targeted therapy for influe... Class II Reported ongoing Distribution: Domestic distribution nationwide. Foreign distribution worldwide. [Official source for cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Materi...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1104-2023%22) Dec 21, 2022 FDA device enforcement ### [cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190](https://isitonrecall.com/recall/fda-device-z-1105-2023-cobas-sars-cov-2-influenza-a-b-qualitative-nucleic-acid-test-for-use-on-the-cobas-5800-6800-8800-sys/) The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress, and delays to targeted therapy for influe... Class II Reported ongoing Distribution: Domestic distribution nationwide. Foreign distribution worldwide. [Official source for cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/880...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1105-2023%22) Dec 21, 2022 FDA device enforcement ### [cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Material number 09233962190](https://isitonrecall.com/recall/fda-device-z-1106-2023-cobas-influenza-a-b-rsv-uc-utility-channel-qualitative-nucleic-acid-test-for-use-on-the-cobas-6800-8/) The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress, and delays to targeted therapy for influe... Class II Reported ongoing Distribution: Domestic distribution nationwide. Foreign distribution worldwide. [Official source for cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1106-2023%22) Sep 8, 2022 FDA device enforcement ### [cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.](https://isitonrecall.com/recall/fda-device-z-0097-2023-cobas-5800-instrument-material-no-08707464001-used-for-automated-polymerase-chain-reaction-pcr-based/) Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses. Class II Reported terminated Distribution: International distribution in the countries of Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Italy, Lithuania, Poland, Portugal, Spain, Sweden, Switzerland... [Official source for cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PC...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0097-2023%22) Nov 16, 2021 FDA device enforcement ### [cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190](https://isitonrecall.com/recall/fda-device-z-0828-2022-cobas-liatsystem-respiratory-virus-panel-nucleic-acid-assay-system-material-number-07341920190/) 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 Influe... Class II Reported ongoing 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. [Official source for cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0828-2022%22) ## Reasons in these listed records - The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress, and delays to targeted therapy for influenza as well as true ... - Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses. - 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. These examples come from this result page and are not a ranking of every recall reason. ## Checking Roche Molecular Systems, Inc. ### Is there a recall on roche molecular systems, inc. right now? This archive contains 5 records, including 4 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Roche Molecular Systems, Inc.](https://isitonrecall.com/check/?q=Roche%20Molecular%20Systems%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)