Roche Molecular Systems Inc
Branchburg, NJ, US
ROCHE MOLECULAR SYSTEMS, INC. appears in FDA device records in Branchburg, NJ. FDA records list 53 510(k) clearances between and , 644 PMA records and 2 registered establishments. As of , FDA records show 66 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 53FDA records hold 53 510(k) clearances for Roche Molecular Systems Inc between 1993 and 2026. The busiest year on record is 2025, with 11. The most recent is 2026, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 1 |
| 1997 | 2 |
| 1998 | 1 |
| 1999 | 3 |
| 2002 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 2 |
| 2017 | 2 |
| 2018 | 2 |
| 2019 | 3 |
| 2020 | 3 |
| 2021 | 5 |
| 2022 | 3 |
| 2023 | 3 |
| 2025 | 11 |
| 2026 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260021 | cobas® BV/CV | PQA | Substantially Equivalent | |
| 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 | QEP | Substantially Equivalent | |
| K253759 | cobas liat CT/NG/MG nucleic acid test | QEP | Substantially Equivalent | |
| K253756 | cobas liat CT/NG nucleic acid test | QEP | Substantially Equivalent | |
| K243753 | cobas liat Bordetella panel nucleic acid test | OZZ | Substantially Equivalent | |
| K252484 | cobas HCV | MZP | Substantially Equivalent | |
| K252481 | cobas CMV | PAB | Substantially Equivalent | |
| K243455 | cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems | QOF | Substantially Equivalent | |
| K243863 | Opulus™ Lymphoma Precision | QIH | Substantially Equivalent | |
| K243406 | cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test | QOF | Substantially Equivalent | |
| K243400 | cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test | QOF | Substantially Equivalent | |
| K243346 | cobas liat SARS-CoV-2 v2 nucleic acid test | QWR | Substantially Equivalent | |
| K240867 | cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems | QQX | Substantially Equivalent | |
| K240217 | cobas® liat CT/NG nucleic acid test | QEP | Substantially Equivalent | |
| K240197 | cobas® liat CT/NG/MG nucleic acid test | QEP | Substantially Equivalent | |
| K223783 | cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System | QWR | Substantially Equivalent | |
| K223591 | cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System | QOF | Substantially Equivalent | |
| K231306 | cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems | QQX | Substantially Equivalent | |
| K221007 | cobas HCV | MZP | Substantially Equivalent | |
| K213804 | cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems | QQX | Substantially Equivalent | |
| K213822 | cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System | OCC | Substantially Equivalent | |
| K212427 | cobas Cdiff nucleic acid test for use on the cobas Liat System | OZN | Substantially Equivalent | |
| K210385 | cobas Cdiff nucleic acid test for use on the cobas Liat System | OZN | Substantially Equivalent | |
| K210234 | cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System | OCC | Substantially Equivalent | |
| K203220 | cobas BKV | QLX | Substantially Equivalent | |
| K202408 | cobas CTNG for use on cobas 6800/8800 systems | QEP | Substantially Equivalent | |
| K202215 | cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit | QMI | Substantially Equivalent | |
| DEN200015 | cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit | QLX | Unknown | |
| 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 | OCC | Substantially Equivalent | |
| DEN190016 | cobas vivoDx MRSA | QIV | Unknown | |
| K191729 | Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System | OCC | Substantially Equivalent | |
| K190433 | cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit | QEP | Substantially Equivalent | |
| K173887 | cobas CT/NG for use on cobas 6800/8800 systems | LSL | Substantially Equivalent | |
| K172913 | cobas Factor II and Factor V Test | NPR | Substantially Equivalent | |
| K171770 | cobas Cdiff Nucleic acid test for use on the cobas Liat System | OZN | Substantially Equivalent | |
| K163184 | cobas® CT/NG v2.0 Test | LSL | Substantially Equivalent | |
| K150617 | cobas HSV 1 and 2 Test | OQO | Substantially Equivalent | |
| K142422 | cobas Cdiff Test | OZN | Substantially Equivalent | |
| K142721 | cobas MRSA/SA Test | NQX | Substantially Equivalent | |
| K140887 | COBAS CT/NG V2.0 TEST | LSL | Substantially Equivalent | |
| K132270 | COBAS CT/NG V2.0 TEST | LSL | Substantially Equivalent | |
| K110923 | COBAS 4800 CT / NG TEST | MKZ | Substantially Equivalent | |
| K091409 | LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727 | NQX | Substantially Equivalent | |
| K043576 | ROCHE AMPLICHIP CYP450 TEST | NTI | Substantially Equivalent | |
| DEN040011 | AMPLICHIP CYP450 TEST, MODEL 04381866190 | NTI | Unknown | |
| K012966 | ROCHE COBAS TAQMAN ANALYZER | JJF | Substantially Equivalent | |
| K974503 | ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE | LSL | Substantially Equivalent | |
| K973707 | ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS | MKZ | Substantially Equivalent | |
| K974342 | ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE | LSL | Substantially Equivalent | |
| K973718 | ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS | MKZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2243471 | 2243471 | ROCHE MOLECULAR SYSTEMS, INC. | 1080 US Highway 202 South, Branchburg, NJ 08876 US | 2026 | and 39 more, listed in full below |
| 3004141078 | 3004141078 | ROCHE MOLECULAR SYSTEMS, INC. | 4300 HACIENDA DRIVE, PLEASANTON, CA 94588 US | 2026 | and 26 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JJFAnalyzer, Chemistry, Micro, For Clinical Use
- MZPAssay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
- NDZAssay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis
- QIHAutomated Radiological Image Processing Software
- QINBabesia Spp. Serological Reagents
- OZZBordetella Pertussis Dna Assay System
- OZNC. Difficile Toxin Gene Amplification Assay
- JQPCalculator/Data Processing Module, For Clinical Use
- JJHClinical Sample Concentrator
- QLTCovid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices
- QIVCulture-Based Short-Term Incubation Antimicrobial Resistance Assay
- PABCytomegalovirus (Cmv) Dna Quantitative Assay
- OZBDengue Nucleic Acid Amplification Assay (Naat)
- SGWDevice To Detect Antibodies To Hepatitis D Virus
- LIODevice, Specimen Collection
- MKZDna Probe, Nucleic Acid Amplification, Chlamydia
- LSLDna-Reagents, Neisseria
- NTIDrug Metabolizing Enzyme Genotyping Systems
- NOPElisa, Antibody, West Nile Virus
- LFZEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- PPMGeneral Purpose Reagent
- PGXGroups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
- MKTHepatitis Viral B Dna Detection
- OQOHerpes Simplex Virus Nucleic Acid Amplification Assay
- QUMHuman Immunodeficiency Virus (Hiv) Viral Load Monitoring Test
- OZEInfluenza A And Influenza B Multiplex Nucleic Acid Assay
- NSUInstrumentation For Clinical Multiplex Test Systems
- MAQKit, Dna Detection, Human Papillomavirus
- QSTLab-Based Hiv Nat Diagnostic And/Or Supplemental Test
- JRCMicro Pipette
- MTLMonitor,Test,Hiv-1
- QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
- QMINucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna
- QLXNucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna
- QEPNucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
- MKQProcessor, Cervical Cytology Slide, Automated
- QJRReagents, 2019-Novel Coronavirus Nucleic Acid
- QTPReagents, Monkeypox Virus Nucleic Acid.
- OOIReal Time Nucleic Acid Amplification System
- QQXRespiratory Specimen Nucleic Acid Sars-Cov-2 Test
- OCCRespiratory Virus Panel Nucleic Acid Assay System
- QWRSimple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings
- OWDSomatic Gene Mutation Detection System
- JQWStation, Pipetting And Diluting, For Clinical Use
- NQXSystem, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
- MWASystem, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex
- MZATest, Equipment, Automated Bloodborne Pathogen
- NPRTest, Factor Ii G20210a Mutations, Genomic Dna Pcr
- NPQTest, Factor V Leiden Mutations, Genomic Dna Pcr
- MZFTest, Hiv Detection
- OUYTrichomonas Vaginalis Nucleic Acid Amplification Test System
- PQAVaginitis And Bacterial Vaginosis Nucleic Acid Detection System
- QFOZika Virus Serological Reagents
Recall records
Showing 25 of 66| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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 | 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 diagnosis. | Class II | Open, Classified | |
| 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 | 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 diagnosis. | Class II | Open, Classified | |
| Z-1104-2023 | cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190 | 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 diagnosis. | Class II | Open, Classified | |
| Z-0097-2023 | cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings. | Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses. | Class II | Terminated | |
| 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 Influenza B results. | Class II | Open, Classified | |
| Z-0083-2022 | cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190 | False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment | Class II | Open, Classified | |
| Z-2498-2021 | cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190 | Customers have reported an increased number of false positive SARS-CoV-2 results. | Class II | Terminated | |
| Z-1414-2021 | cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190 | Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under emergency use authorization on the cobas Liat analyzer, showed abnormal PCR growth curves | Class II | Open, Classified | |
| 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 | Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under emergency use authorization on the cobas Liat analyzer, showed abnormal PCR growth curves | Class II | Open, Classified | |
| Z-0877-2021 | uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001 | When a user creates a measurement tool annotation in the uPath Enterprise software version 1.1, the measurement value is incorrectly calculated when the measurement is viewed in "Split View" viewing mode and the slides within the case are scanned at different magnifications. | Class II | Terminated | |
| Z-0846-2021 | The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection system for nucleic acids. The analyzer is intended to be used as an in-vitro diagnostic or screening system providing real time PCR amplification and detection for human samples within the system. The cobas x 480 instrument and cobas z 480 analyzer are to be used by laboratory professionals trained in laboratory techniques and by instruction on the use of the system and analyzer. In the U.S. the cobas z 480 analyzer is used for automated amplification and detection purposes for the following assays: cobas 4800 BRAF V600 Mutation Test cobas Cdiff Test for use on the cobas 4800 System cobas CT/NG v2.0 Test cobas EGFR Mutation Test v2 cobas Factor II and Factor V Test cobas 4800 HPV Test cobas HSV 1 and 2 Test for use on the cobas 4800 System cobas KRAS Mutation Test cobas MRSA/SA Test for use on the cobas 4800 System | Dirty Lens May Cause Invalid or False Positive Results | Class II | Terminated | |
| Z-2551-2020 | MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 - Product Usage: This protocol is intended for pipetting samples into a MagNA Pure 96 Processing Cartridge (purification rack position 1) before a purification run. | When using Sample Transfer protocol version 3.0, the drop catcher is not activated on the MagNA Pure 96 instrument, which introduces a potential risk for cross-contamination leading to erroneous results. | Class II | Terminated | |
| Z-1956-2018 | MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clinical sample extractor. It extracts nucleic acids from various sample types, sample tubes, and volume inputs for multiple downstream applications. The main features of the system are : Scalable purification of 1 to 24 samples Primary/secondary tube handling Inventory and sample management via barcodes Efficient order management via host The MagNA Pure 24 System offers 4 run types: Purification (rack) run Purification (cartridge) run Post Elution run Sample transfer run | Cross-contamination of samples has been reported when running the existing protocol on the system with the rack-based purification run. | Class II | Terminated | |
| Z-1195-2018 | Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic. | The cobas MRSA/SA tests may have decreased performance compared to the analytical sensitivity for MSRA detection. A screening failure can lead to potential infection in the colonized patient being tested as well as the spread of MSRA to others. The United States is not impacted, as the cobas MRSA/SA nucleic acid test for use on the cobas liat system is not available in the US. | Class II | Terminated | |
| Z-0750-2017 | LightMix Zika rRT-PCR Test The LightMix Zika rRT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of RNA from the Zika virus in serum or EDTA plasma from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated). Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories. Results are for the identification of Zika virus RNA. Zika virus RNA is generally detectable in serum during the acute phase of infection (approximately 7 days following onset of symptoms, if present). Positive results are indicative of current infection. Laboratories are required to report all positive results to the appropriate public health authorities. Within the United States and its territories positive results must be reported to appropriate state/local public health authorities. Negative results do not preclude Zika virus infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. The LightMix Zika rRT-PCR Test is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of realtime PCR and in vitro diagnostic procedures. The Test is only for use under the Food and Drug Administration s Emergency Use Authorization. | The LightCycler 480 algorithm used for the LightMix Zika rRT-PCR Test, EUA (catalog number 07987897001) occasionally (~1% of the time) calls a positive result for a negative sample if there is an inflection point in the fluorescence signal. | Class II | Terminated | |
| Z-2203-2016 | cobas Liat Influenza A/B Quality Control Kit; For use with cobas Liat Influenza A/B Assay. | Kit labeled with the incorrect expiration date. | Class III | Terminated | |
| Z-2216-2016 | cobas Liat Analyzer | Device was released with default pcal/gain settings for photometers instead of the pcal/gain settings that are required for release. The default settings can potentially lead to the generation of erroneous or invalid results. | Class II | Terminated | |
| Z-2254-2016 | cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA: 07247737190 Device Identifier: EGFR v2.0: 00875197005448 cfDNA: 00875197005424 Product Usage: A real time PCR Test for the qualitative detection and identifications of mutations n exons 18, 19, 20 and 21 of the epidermal growth factor receptor (EGFR) gene in DNA derived from formalin-fixed paraffin-embedded (FFPET) tumor tissue or plasma from non-small cell lung cancer (NSCLC) patients. The test also is intended to be used as an aid in selecting patients with NSCLC for therapy with an EGFR tyrosine kinase inhibitor (TKI). | During internal studies using contrived plasma specimens, several mutations (L8568R, Exon 19 deletion, T790M) inconsistently generated "No Mutation Detected" (ie False Negative ) result with the cobas EGFR mutation Text V2.0 when utilizing the cobas cfDNA Sample Preparation kit. | Class II | Terminated | |
| Z-1830-2016 | cobas EGFR Mutation Test, v2 and cobas cfDNA Sample Preparation Hungarian Translation Instructions for Use | An error was found within the Hungarian translations of the cobas EGFR Mutation Test v2 Instructions for Use (M/N 07340761001-01HU, Doc Rev. 1.0, Dated 08/2015) and the cobas cfDNA Sample Preparation Kit Instructions for Use (M/N 07573758001-01HU, Doc. Rev. 1.0, Dated 05/2015). | Class II | Terminated | |
| Z-1578-2016 | Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems | The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID. | Class II | Terminated | |
| Z-2543-2015 | 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 LED printed circuit board assemblies (PCBA) in certain cobas Liat Analyzers. | Class II | Terminated | |
| Z-1320-2015 | cobas EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay | False positive results for Exon 20 insertion mutations are being detected with the cobas EGFR Mutation Test, kit batch T08661. | Class III | Terminated | |
| Z-0999-2015 | cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the identification of mutations in codons 12,13 and 61 of the KRAS Gene in DNA derived from formalin-fixed paraffin-embedded human colorectal and non-small cell lung cancer tissues. | cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator. | Class III | Terminated | |
| Z-1111-2014 | cobas PCR Urine Kit 100 PKT IVD cobas PCR Female Swab Kit 100 PKT IVD cobas PCR media 100T IVD cobas PCR Female Swab Kit 100 PKT JPN-IVD Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 The cobas PCR media serves as a nucleic acid stabilizing transport and storage medium for gynecological specimens and is contained in the cobas PCR Female Swab Kit, cobas PCR Urine kit, and cobas PCR media 100 T kit. -The cobas PCR Urine Sample Kit is used to collect and transport urine specimens. Use this collection kit only with the cobas CT/NG Test. - The cobas PCR Female Swab Sample Kit is used to collect and transport endocervical and vaginal swab specimens. Use this collection kit only with the cobas CT/NG Test NOTE: This collection kit should not be used for collection of female urine specimens. o For endocervical swab specimens, collections are to be performed by a clinician. o For vaginal swab specimens, collections are to be performed by a clinician or by the patient (self-collection) -In US labeling, it indicates Self collection in a clinical setting. - In ex-US labeling, it indicates Clinician Instructed Self- Collection and Ensure the patient has read and understood the following self-collection instructions before providing a collection kit. - In some countries (e.g., UK), the sample collection kit is provided as self-collection for home / personal use, which may not be used in a controlled clinical setting and it is unknown if any instructions are provided. - The cobas PCR media kit is used to stabilize and transport urine specimens. Use this kit only with the cobas CT/NG Test. | Numerous complaints have been filed that leaking cobas PCR media 4.3 mL IVD have been received from different lots of the cobas PCR Urine kits, cobas PCR Female Swab kits, and cobas PCR media kits. | Class II | Terminated | |
| Z-2173-2013 | KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US highway 202 South Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 USA The cobas HPV Test is a qualitative in vitro test for the detection of Human Papillomavirus in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies types HPV16 and HPV18 while concurrently detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). The cobas HPV Test is indicated: (a) To screen patients 21 years and older with ASC-US (Atypical squamous cells of undetermined significance) cervical cytology test results to determine the need for referral to colposcopy. (b) To be used in patients 21 years and older with ASC-US cervical cytology results, to assess the presence or absence of high-risk HPV genotypes 16 and 18. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy. (c) In women 30 years and older, the cobas HPV Test can be used with cervical cytology to adjunctively screen to assess the presence or absence of high risk HPV types. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. (d) In women 30 years and older, the cobas HPV Test can be used to assess the presence or absence of HPV genotypes 16 and 18. This information, together with the physicians assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. Cervical specimens that may be tested with the cobas HPV Test include the following liquid based collection media and collection device: " ThinPrep Pap TestTM PreservCyt Solution " Endocervical Brush/Spatula | During an internal investigation, a formulation error that occurred was identified during the manufacture of the cobas 4800 HPV Master Mix reagent that was packaged in four (4) cobas 4800 AMP/DET kits, US- and CE-IVD (240 and 960 test kit configurations). Examination of the batch production record of the material revealed there was an error in the tare weight used for the carboy during the fina | Class II | Terminated |
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