Roche Molecular Systems, Inc.
Roche Molecular Systems, Inc. holds FDA 510(k) medical device clearances, first cleared 1993, most recent 2026, with 42 FDA device recalls on record.
Top product codes for Roche Molecular Systems, Inc.
FDA recalls by Roche Molecular Systems, Inc.
10 most recent of 42- Z-1105-2023 — cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190
- Z-1106-2023 — cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Material number 09233962190
- Z-1104-2023 — cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190
- Z-0097-2023 — cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.
- Z-0828-2022 — cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
- Z-0083-2022 — cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
- Z-2498-2021 — cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
- Z-1414-2021 — cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
- 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
- Z-0877-2021 — uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Roche Molecular Systems, Inc.
- K260045 — cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190) +1 more
- K260047 — cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190) +1 more
- K260021 — cobas® BV/CV
- K260917 — cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems
- K253756 — cobas liat CT/NG nucleic acid test
- K253759 — cobas liat CT/NG/MG nucleic acid test
- K243753 — cobas liat Bordetella panel nucleic acid test
- K252481 — cobas CMV
- K252484 — cobas HCV
- K243455 — cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems
- K243863 — Opulus Lymphoma Precision
- K243400 — cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test
- K243406 — cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test
- K243346 — cobas liat SARS-CoV-2 v2 nucleic acid test
- K240867 — cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems
- K240217 — cobas® liat CT/NG nucleic acid test
- K240197 — cobas® liat CT/NG/MG nucleic acid test
- K223783 — cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System
- K223591 — cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System
- K231306 — cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems
- K221007 — cobas HCV
- K213804 — cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems
- K213822 — cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System
- K212427 — cobas Cdiff nucleic acid test for use on the cobas Liat System
- K210385 — cobas Cdiff nucleic acid test for use on the cobas Liat System
- K210234 — cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System
- K203220 — cobas BKV
- K202408 — cobas CTNG for use on cobas 6800/8800 systems
- K202215 — cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit
- DEN200015 — cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit
- K200065 — cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System
- DEN190016 — cobas vivoDx MRSA
- K191729 — Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System
- K190433 — cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit
- K173887 — cobas CT/NG for use on cobas 6800/8800 systems
- K172913 — cobas Factor II and Factor V Test
- K171770 — cobas Cdiff Nucleic acid test for use on the cobas Liat System
- K163184 — cobas® CT/NG v2.0 Test
- K150617 — cobas HSV 1 and 2 Test
- K142422 — cobas Cdiff Test
- K142721 — cobas MRSA/SA Test
- K140887 — COBAS CT/NG V2.0 TEST
- K132270 — COBAS CT/NG V2.0 TEST
- K110923 — COBAS 4800 CT / NG TEST
- K091409 — LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727
- K043576 — ROCHE AMPLICHIP CYP450 TEST
- DEN040011 — AMPLICHIP CYP450 TEST, MODEL 04381866190
- K012966 — ROCHE COBAS TAQMAN ANALYZER
- K974503 — ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
- K973707 — ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
- K974342 — ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
- K973718 — ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
- K964507 — ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST
- K964506 — ROCHE COBAS AMPLICOR ANALYZER
- K922906 — AMPLICOR CHLAMYDIA TRACHOMATIS TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.