Roche Molecular Systems, Inc.
Medical device manufacturer in Pleasanton, CA.
52510(k) clearances
15PMA approvals
52recalls
Device types
- QEP Nucleic Acid Detection System For Non-Viral… 7
- LSL Dna-Reagents, Neisseria 6
- MKZ Dna Probe, Nucleic Acid Amplification… 5
- OZN C. Difficile Toxin Gene Amplification Assay 5
- OCC Respiratory Virus Panel Nucleic Acid Assay… 4
- QOF Multi-Target Respiratory Specimen Nucleic… 4
- QQX Respiratory Specimen Nucleic Acid… 3
- JJF Analyzer, Chemistry, Micro, For Clinical Use 2
- NQX System, Nucleic Acid Amplification Test… 2
- MZP Assay, Hybridization And/Or Nucleic Acid… 2
- QWR Simple Point-Of-Care Device To Detect… 2
- PGX Groups A, C And G Beta-Hemolytic… 1
- PQA Vaginitis And Bacterial Vaginosis Nucleic… 1
- OZZ Bordetella Pertussis Dna Assay System 1
- PAB Cytomegalovirus (Cmv) Dna Quantitative Assay 1
- QIH Automated Radiological Image Processing… 1
- QLX Nucleic Acid Amplification Test For The… 1
- QMI Nucleic Acid Amplification Test For The… 1
- NPR Test, Factor Ii G20210a Mutations, Genomic… 1
- OQO Herpes Simplex Virus Nucleic Acid… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K260047 | cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas…PGX · Traditional | 08/28/2026SE |
| K260045 | cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas®…OZN · Traditional | 08/28/2026SE |
| K260021 | cobas® BV/CVPQA · Traditional | 07/16/2026SE |
| K260917 | cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the…QEP · Traditional | 07/08/2026SE |
| K253759 | cobas liat CT/NG/MG nucleic acid testQEP · Dual Track | 05/15/2026SE |
| K253756 | cobas liat CT/NG nucleic acid testQEP · Dual Track | 05/15/2026SE |
| K243753 | cobas liat Bordetella panel nucleic acid testOZZ · Dual Track | 11/20/2025SE |
| K252484 | cobas HCVMZP · Traditional | 11/03/2025SE |
| K252481 | cobas CMVPAB · Traditional | 11/03/2025SE |
| K243455 | cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 SystemsQOF · Traditional | 07/31/2025SE |
| K243863 | Opulus Lymphoma PrecisionQIH · Traditional | 05/30/2025SE |
| K243406 | cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid testQOF · Dual Track | 04/25/2025SE |
| K243400 | cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid testQOF · Dual Track | 04/25/2025SE |
| K243346 | cobas liat SARS-CoV-2 v2 nucleic acid testQWR · Dual Track | 04/11/2025SE |
| K240867 | cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 SystemsQQX · Traditional | 02/11/2025SE |
| K240217 | cobas® liat CT/NG nucleic acid testQEP · Dual Track | 01/17/2025SE |
| K240197 | cobas® liat CT/NG/MG nucleic acid testQEP · Dual Track | 01/16/2025SE |
| K223783 | cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat SystemQWR · Dual Track | 12/04/2023SE |
| K223591 | cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® SystemQOF · Dual Track | 07/27/2023SE |
| K231306 | cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 SystemsQQX · Special | 06/01/2023SE |
| K221007 | cobas HCVMZP · Traditional | 11/04/2022SE |
| K213804 | cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 SystemsQQX · Traditional | 10/22/2022SE |
| K213822 | cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat SystemOCC · Special | 07/06/2022SE |
| K212427 | cobas Cdiff nucleic acid test for use on the cobas Liat SystemOZN · Special | 10/20/2021SE |
| K210385 | cobas Cdiff nucleic acid test for use on the cobas Liat SystemOZN · Special | 09/09/2021SE |
| K210234 | cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat SystemOCC · Special | 02/16/2021SE |
| K203220 | cobas BKVQLX · Traditional | 01/29/2021SE |
| K202408 | cobas CTNG for use on cobas 6800/8800 systemsQEP · Traditional | 01/21/2021SE |
| K202215 | cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control KitQMI · Traditional | 09/02/2020SE |
| K200065 | cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza…OCC · Special | 02/10/2020SE |
| K191729 | Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat SystemOCC · Special | 07/24/2019SE |
| K190433 | cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas…QEP · Traditional | 05/22/2019SE |
| K173887 | cobas CT/NG for use on cobas 6800/8800 systemsLSL · Traditional | 03/21/2018SE |
| K172913 | cobas Factor II and Factor V TestNPR · Traditional | 01/12/2018SE |
| K171770 | cobas Cdiff Nucleic acid test for use on the cobas Liat SystemOZN · Traditional | 09/12/2017SE |
| K163184 | cobas® CT/NG v2.0 TestLSL · Traditional | 02/09/2017SE |
| K150617 | cobas HSV 1 and 2 TestOQO · Traditional | 06/01/2015SE |
| K142422 | cobas Cdiff TestOZN · Traditional | 05/20/2015SE |
| K142721 | cobas MRSA/SA TestNQX · Traditional | 12/17/2014SE |
| K140887 | Cobas Ct/Ng V2.0 TestLSL · Special | 05/05/2014SE |
| K132270 | Cobas Ct/Ng V2.0 TestLSL · Traditional | 12/02/2013SE |
| K110923 | Cobas 4800 CT / NG TestMKZ · Traditional | 01/24/2012SE |
| K091409 | Lightcycler Mrsa Advanced Test for Use with the Lightcycler 2.0 Instrument, Model 05205727NQX · Traditional | 07/06/2010SE |
| K043576 | Roche Amplichip CYP450 TestNTI · Traditional | 01/10/2005SE |
| K012966 | Roche Cobas Taqman AnalyzerJJF · Traditional | 02/01/2002SE |
| K974503 | Roche Amplicor Ct/Ng Test for Neisseria GonorrhoeaeLSL · Traditional | 12/01/1999SE |
| K973707 | Roche Amplicor Ct/Ng Test for Chlamydia TrachomatisMKZ · Traditional | 08/04/1999SE |
| K974342 | Roche Cobas Amplicor Ct/Ng Test for Neisseria GonorrhoeaeLSL · Traditional | 05/28/1999SE |
| K973718 | Roche Cobas Amplicor Ct/Ng Test for Chlamydia TrachomatisMKZ · Traditional | 12/15/1998SE |
| K964507 | Roche Cobas Amplicor Chlamydia Trachomatis TestMKZ · Traditional | 06/13/1997SE |
| K964506 | Roche Cobas Amplicor AnalyzerJJF · Traditional | 05/21/1997SE |
| K922906 | Amplicor Chlamydia Trachomatis TestMKZ · Traditional | 06/15/1993SE |
PMA approvals
- P190028 cobas HPV for use on the cobas 6800/8800 Systems · 04/03/2020 · 25 supplements
- P160041 Cobas CMV · 06/01/2017 · 46 supplements
- P150044 cobas EGFR MUTATION TEST v2 · 09/28/2016 · 0 supplements
- P150047 cobas EGFR MUTATION TEST v2 · 06/01/2016 · 2 supplements
- P150015 Cobas HCV Test · 10/14/2015 · 42 supplements
- P150014 Cobas HBV Test · 10/14/2015 · 57 supplements
- P140023 Cobas Kras Mutation Test · 05/07/2015 · 32 supplements
- P110037 Cobas® Ampliprep/Cobas® Taqman® CMV Test (Cap/Ctm CMV Test) · 07/05/2012 · 64 supplements
- P110020 Cobas 4800 Braf V600 Mutation Test · 08/17/2011 · 44 supplements
- P100020 Cobas HPV Test · 04/19/2011 · 64 supplements
- P060030 Cobas Ampliprep/Cobas Taqman HCV Test · 10/30/2008 · 83 supplements
- P050028 Cobas Taqman HBV Test · 09/04/2008 · 88 supplements
- P000010 Amplicor Hepatitis C Virus (HCV) Test Version 2.0 · 07/05/2001 · 22 supplements
- P000012 Cobas Amplicor (TM) Hepatitis C Virus (HCV) Test, V2.0 · 07/03/2001 · 51 supplements
- P940040 Amplicor (TM) Mycobacterium Tuberculosis Test · 11/26/1996 · 9 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1106-2023 Class II | cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on…The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A… | 12/21/2022Open, Classified |
| Z-1105-2023 Class II | cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas…The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A… | 12/21/2022Open, Classified |
| Z-1104-2023 Class II | cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800…The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A… | 12/21/2022Open, Classified |
| Z-0097-2023 Class II | cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain…Reported false positive and invalid results on the affected devices due to anomalous baselines. This may… | 09/08/2022Terminated |
| Z-0828-2022 Class II | cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number…Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels… | 11/16/2021Open, Classified |
| Z-0083-2022 Class II | cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number…False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR… | 09/03/2021Open, Classified |
| Z-2498-2021 Class II | cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number…Customers have reported an increased number of false positive SARS-CoV-2 results. | 08/04/2021Terminated |
| Z-1414-2021 Class II | cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number:…Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the… | 03/25/2021Open, Classified |
| Z-1413-2021 Class II | cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus…Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the… | 03/25/2021Open, Classified |
| Z-0877-2021 Class II | uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and…When a user creates a measurement tool annotation in the uPath Enterprise software version 1.1, the… | 11/23/2020Terminated |
| Z-0846-2021 Class II | The cobas z 480 analyzer including dedicated software for IVD use is a plate-based…Dirty Lens May Cause Invalid or False Positive Results | 11/19/2020Terminated |
| Z-2551-2020 Class II | MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 -…When using Sample Transfer protocol version 3.0, the drop catcher is not activated on the MagNA Pure 96… | 06/03/2020Terminated |
| Z-1956-2018 Class II | MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a…Cross-contamination of samples has been reported when running the existing protocol on the system with the… | 05/02/2018Terminated |
| Z-1195-2018 Class II | Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro…The cobas MRSA/SA tests may have decreased performance compared to the analytical sensitivity for MSRA… | 10/27/2017Terminated |
| Z-0750-2017 Class II | LightMix Zika rRT-PCR Test The LightMix Zika rRT-PCR Test is a real-time RT-PCR test…The LightCycler 480 algorithm used for the LightMix Zika rRT-PCR Test, EUA (catalog number 07987897001)… | 11/16/2016Terminated |
| Z-2203-2016 Class III | cobas Liat Influenza A/B Quality Control Kit; For use with cobas Liat Influenza A/B Assay.Kit labeled with the incorrect expiration date. | 05/17/2016Terminated |
| Z-2216-2016 Class II | cobas Liat AnalyzerDevice was released with default pcal/gain settings for photometers instead of the pcal/gain settings that… | 05/09/2016Terminated |
| Z-2254-2016 Class II | cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA:…During internal studies using contrived plasma specimens, several mutations (L8568R, Exon 19 deletion… | 04/05/2016Terminated |
| Z-1830-2016 Class II | cobas EGFR Mutation Test, v2 and cobas cfDNA Sample Preparation Hungarian Translation…An error was found within the Hungarian translations of the cobas EGFR Mutation Test v2 Instructions for Use… | 03/15/2016Terminated |
| Z-1578-2016 Class II | Hand-Held Scanner USB IT3800 For sample identification and tracking when used with…The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample… | 03/03/2016Terminated |
| Z-2543-2015 Class II | cobas Liat Analyzer, for in vitro diagnostic use.Due to a supplier issue, the incorrect green and amber LED components were used in the manufacture of the… | 07/24/2015Terminated |
| Z-1320-2015 Class III | cobas EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assayFalse positive results for Exon 20 insertion mutations are being detected with the cobas EGFR Mutation Test… | 01/13/2015Terminated |
| Z-0999-2015 Class III | cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the…cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator. | 12/18/2014Terminated |
| Z-1111-2014 Class II | cobas PCR Urine Kit 100 PKT IVD cobas PCR Female Swab Kit 100 PKT IVD cobas PCR media…Numerous complaints have been filed that leaking cobas PCR media 4.3 mL IVD have been received from… | 01/06/2014Terminated |
| Z-2173-2013 Class II | KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080…During an internal investigation, a formulation error that occurred was identified during the manufacture of… | 07/25/2013Terminated |
| Z-1346-2013 Class II | cobas 4800 system z480 instrument. Integrates fully automated total nucleic acid…In rare instances, channel shifted results have been generated with cobas 4800 assays run on v1.1.1 of the… | 04/01/2013Terminated |
| Z-0762-2013 Class II | COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.The COBAS TaqMan MTB Test Definition Files (TDF) v3.0, for both CE-IVD and JPN-IVD tests, being used with… | 11/28/2012Terminated |
| Z-0614-2013 Class II | COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample…Certain COBAS AmpliPrep instruments using AMPILINK software v.3.3.4 had the sample clot detection flagging… | 10/11/2012Terminated |
| Z-0188-2013 Class III | cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems…It was identified that BRAF controls dispositioned as "Internal Use Only" were incorrectly packaged into… | 07/31/2012Terminated |
| Z-0493-2013 Class II | DataCare POC is an information management system that provides data management…Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | 07/16/2012Terminated |
| Z-0492-2013 Class II | DataCara GM is an information management system that provides data management…Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | 07/16/2012Terminated |
| Z-0491-2013 Class II | DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger…Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | 07/16/2012Terminated |
| Z-0490-2013 Class II | The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated…Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | 07/16/2012Terminated |
| Z-0489-2013 Class II | The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully…Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | 07/16/2012Terminated |
| Z-0488-2013 Class II | LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time…Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | 07/16/2012Terminated |
| Z-0487-2013 Class II | LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection…Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | 07/16/2012Terminated |
| Z-0486-2013 Class II | The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for…Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | 07/16/2012Terminated |
| Z-0485-2013 Class II | The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with…Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | 07/16/2012Terminated |
| Z-0484-2013 Class II | Data Station AMPLILINK software is an instrument user interface/ data management…Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue. | 07/16/2012Terminated |
| Z-2403-2012 Class II | Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and…When using a Laboratory Information system (LIS) with automated systems utilizing AMPLILINK software v3.2… | 04/23/2012Terminated |
| Z-2159-2012 Class III | Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The Cobas…During the real-time stability testing for the cobas KRAS Mutation Test on the commercial lot PO6778, it was… | 02/24/2012Terminated |
| Z-2209-2012 Class II | COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input…Certain lots of COBAS AmpliPrep (CAP) S-tube Input (Box of 12 bags 12x24 S-tube and 12x24 S-clip) can cause… | 02/01/2012Terminated |
| Z-2587-2011 | COBAS AmpliPrep / COBAS TaqMan HCV Test, CE-IVD The COBAS AmpliPrep/COBAS TaqMan HCV…The COBAS Ampliprep/COBAS TaqMan HCV Test has been shown to under-quantitate a subset of genotype 4 patient… | 04/14/2011Terminated |
| Z-2586-2011 | COBAS AmpliPrep / COBAS TaqMan HCV Test, US-IVD The COBAS AmpliPrep/COBAS TaqMan HCV…The COBAS Ampliprep/COBAS TaqMan HCV Test has been shown to under-quantitate a subset of genotype 4 patient… | 04/14/2011Terminated |
| Z-2566-2011 | Factor V Leiden Kit Light Cycler Instrument; Manufactured in Germany for Roche Molecular…Roche Molecular Systems has decided to discontinue marketing the Factor II (Prothrombin) G20210A Kit and the… | 03/31/2011Terminated |
| Z-2565-2011 | Factor II (Prothrombin) G20210A Kit Light Cycler Instrument; Manufactured in Germany for…Roche Molecular Systems has decided to discontinue marketing the Factor II (Prothrombin) G20210A Kit and the… | 03/31/2011Terminated |
| Z-1459-2011 | COBAS AmpliPrep/COBAS TaqMan HBV v2.0 US-IVD; COBAS AmpliPrep/COBAS TaqMan HBV v2.0 CE-IVDThere is an issue regarding liquid level detection of the CS1 Magnetic Glass Particles (MGP) Reagent… | 12/28/2010Terminated |
| Z-1928-2009 | AMPLILINK Software, version 3.1.0 to 3.2.2 with COBAS AmpliPrep. Catalog number…Software bug: A unique series of events involving the COBAS AmpliPrep instrument running AMPLILINK software… | 06/02/2009Terminated |
| Z-1107-2007 | Amplilink Software Versions 1.1, 1.3, 1.4, 2.41 COBAS AmpliPrep/COBAS Amplicor HCV Test…For select COBAS AMPLICOR Tests run on the COBAS AMPLICOR Analyzer in conjunction with AMPLILINK software, a… | 05/21/2007Terminated |
| Z-1106-2007 | Amplilink Software versions 1.1, 1.3, 1.4, 2.41. COBAS Amplicor CTA & NGA TestsFor select COBAS AMPLICOR Tests run on the COBAS AMPLICOR Analyzer in conjunction with AMPLILINK software, a… | 05/21/2007Terminated |
| Z-0735-2007 | AmpliChip CYP450 Test, CE-IVD, M/N: 4381866190, Roche Molecular Systems, Inc.The current package insert for the AmpliChip CYP 450 test, lists an incorrect part number for DNase I. The… | 03/09/2007Terminated |
| Z-0734-2007 | AmpliChip CYP450 Test-US IVD-M/N: 4591402190, Roche Molecular DiagnosticsThe current package insert for the AmpliChip CYP 450 test, lists an incorrect part number for DNase I. The… | 03/09/2007Terminated |