Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Roche. FDA records under 3 spellings of its name, each linked to the record. See the Roche group view.
As of Nov 14, 2026, FDA's public records list Roche Molecular Systems with 52 510(k) clearances, 42 device recalls and 1 AI-enabled device. The most recent is a 510(k) clearance dated Aug 28, 2026: cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas St….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 28, 2026 | cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190)K260047 · PGX | 510(k) clearances |
| Aug 28, 2026 | cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190)K260045 · OZN | 510(k) clearances |
| Jul 16, 2026 | cobas® BV/CVK260021 · PQA | 510(k) clearances |
| Jul 8, 2026 | cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systemsK260917 · QEP | 510(k) clearances |
| May 15, 2026 | cobas liat CT/NG nucleic acid testK253756 · QEP | 510(k) clearances |
| May 15, 2026 | cobas liat CT/NG/MG nucleic acid testK253759 · QEP | 510(k) clearances |
| Nov 20, 2025 | cobas liat Bordetella panel nucleic acid testK243753 · OZZ | 510(k) clearances |
| Nov 3, 2025 | cobas CMVK252481 · PAB | 510(k) clearances |
| May 30, 2025 | Opulus Lymphoma PrecisionK243863 · Radiology | AI-enabled devices |
| Dec 21, 2022 | cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190Class II · The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct valu | Device recalls |
| Dec 21, 2022 | cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Material number 0923396Class II · The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct valu | Device recalls |
| Dec 21, 2022 | cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190Class II · The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct valu | Device recalls |
| Sep 8, 2022 | cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboClass II · Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneo | Device recalls |
| Nov 16, 2021 | cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190Class II · Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels (background si | Device recalls |
| Sep 3, 2021 | cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190Class II · False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, | Device recalls |
| Aug 4, 2021 | cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190Class II · Customers have reported an increased number of false positive SARS-CoV-2 results. | Device recalls |
| Mar 25, 2021 | cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190Class II · Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV- | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
