Data / Medical devices / United States / Roche Molecular Systems, Inc.

Roche Molecular Systems, Inc.: FDA-registered device maker in Branchburg, NJ, United States, 32 510(k) clearances and 13 PMA approvals

Name: Roche Molecular Systems, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Roche Molecular Systems, Inc. is registered with the FDA (registration 2243471) in Branchburg, NJ, United States. It lists 49 device types. The FDA files 32 510(k) clearances and 13 PMA approvals under its listings, the newest dated July 16, 2026. 38 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this one Watch Roche Molecular Systems, Inc.

FDA registration number: 2243471
Address: 1080 US Highway 202 South, Branchburg, NJ, United States, 08876
Owner or operator: Roche Diagnostics Operations Inc. (9039767)
Roles: Manufacturer, Manufacturer for export, Specification developer
First device listed: March 6, 2001
Registered through: 2027
Brand names listed: 579-2-RSA Dynamic Interface v1.1, 713-2-cobase 8100 v1.5, 770-1-CCM-AOB v1.1, A1CD, cobas c 503, AMPLICOR® Respiratory Specimen Preparation Kit (100 Tests), AMPLILINK Software Version 3.4, ASSY RGT DISPENSER CARD ISH PROBE, AVENIO Edge System and more

Devices it lists

Device	Product code	Class	Role	Source
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus	MZP	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis	NDZ	1	Manufacturer for export	accessdata.fda.gov
Babesia Spp. Serological Reagents	QIN	N	Manufacturer for export	accessdata.fda.gov
Bordetella Pertussis Dna Assay System	OZZ	2	Manufacturer	accessdata.fda.gov
C. Difficile Toxin Gene Amplification Assay	OZN	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Calculator/Data Processing Module, For Clinical Use	JQP	1	Manufacturer	accessdata.fda.gov
Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices	QLT	N	Manufacturer	accessdata.fda.gov
Culture-Based Short-Term Incubation Antimicrobial Resistance Assay	QIV	2	Manufacturer	accessdata.fda.gov
Cytomegalovirus (Cmv) Dna Quantitative Assay	PAB	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Dengue Nucleic Acid Amplification Assay (Naat)	OZB	2	Manufacturer for export	accessdata.fda.gov
Device To Detect Antibodies To Hepatitis D Virus	SGW	2	Manufacturer for export	accessdata.fda.gov
Device, Specimen Collection	LIO	1	Manufacturer for export	accessdata.fda.gov
Dna Probe, Nucleic Acid Amplification, Chlamydia	MKZ	1	Manufacturer, Manufacturer for export	accessdata.fda.gov
Dna-Reagents, Neisseria	LSL	2	Manufacturer	accessdata.fda.gov
Elisa, Antibody, West Nile Virus	NOP	2	Manufacturer for export	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus	LFZ	2	Manufacturer for export	accessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	1	Specification developer	accessdata.fda.gov
General Purpose Reagent	PPM	1	Manufacturer, Manufacturer for export	accessdata.fda.gov
Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System	PGX	2	Manufacturer	accessdata.fda.gov
Hepatitis Viral B Dna Detection	MKT	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Herpes Simplex Virus Nucleic Acid Amplification Assay	OQO	2	Manufacturer	accessdata.fda.gov
Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test	QUM	2	Manufacturer	accessdata.fda.gov
Influenza A And Influenza B Multiplex Nucleic Acid Assay	OZE	2	Manufacturer	accessdata.fda.gov
Instrumentation For Clinical Multiplex Test Systems	NSU	2	Manufacturer, Specification developer	accessdata.fda.gov
Kit, Dna Detection, Human Papillomavirus	MAQ	3	Manufacturer, Manufacturer for export	accessdata.fda.gov
Lab-Based Hiv Nat Diagnostic And/Or Supplemental Test	QST	2	Manufacturer	accessdata.fda.gov
Micro Pipette	JRC	1	Manufacturer	accessdata.fda.gov
Monitor,Test,Hiv-1	MTL	3	Manufacturer for export	accessdata.fda.gov
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	QOF	2	Manufacturer	accessdata.fda.gov
Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna	QMI	2	Manufacturer	accessdata.fda.gov
Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna	QLX	2	Manufacturer	accessdata.fda.gov
Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections	QEP	2	Manufacturer	accessdata.fda.gov
Processor, Cervical Cytology Slide, Automated	MKQ	3	Manufacturer for export	accessdata.fda.gov
Reagents, 2019-Novel Coronavirus Nucleic Acid	QJR	N	Manufacturer, Manufacturer for export	accessdata.fda.gov
Reagents, Monkeypox Virus Nucleic Acid.	QTP	N	Manufacturer	accessdata.fda.gov
Real Time Nucleic Acid Amplification System	OOI	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Respiratory Specimen Nucleic Acid Sars-Cov-2 Test	QQX	2	Manufacturer	accessdata.fda.gov
Respiratory Virus Panel Nucleic Acid Assay System	OCC	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings	QWR	2	Manufacturer	accessdata.fda.gov
Somatic Gene Mutation Detection System	OWD	3	Manufacturer, Manufacturer for export	accessdata.fda.gov
Station, Pipetting And Diluting, For Clinical Use	JQW	1	Manufacturer	accessdata.fda.gov
System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection	PFX	2	Manufacturer for export	accessdata.fda.gov
System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen	NQX	2	Manufacturer	accessdata.fda.gov
Test, Factor Ii G20210a Mutations, Genomic Dna Pcr	NPR	2	Manufacturer	accessdata.fda.gov
Test, Factor V Leiden Mutations, Genomic Dna Pcr	NPQ	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Test, Hiv Detection	MZF	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Trichomonas Vaginalis Nucleic Acid Amplification Test System	OUY	2	Manufacturer for export	accessdata.fda.gov
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System	PQA	2	Manufacturer	accessdata.fda.gov
Zika Virus Serological Reagents	QFO	2	Manufacturer for export	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 16, 2026	K260021	cobas® BV/CV	PQA	Substantially Equivalent	Roche Molecular Systems, Inc.	accessdata.fda.gov
May 15, 2026	K253759	cobas liat CT/NG/MG nucleic acid test	QEP	Substantially Equivalent	Roche Molecular Systems, Inc.	accessdata.fda.gov
November 20, 2025	K243753	cobas liat Bordetella panel nucleic acid test	OZZ	Substantially Equivalent	Roche Molecular Systems, Inc.	accessdata.fda.gov
July 31, 2025	K243455	cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems	QOF	Substantially Equivalent	Roche Molecular Systems, Inc.	accessdata.fda.gov
April 25, 2025	K243406	cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test	QOF	Substantially Equivalent	Roche Molecular Systems, Inc.	accessdata.fda.gov
April 25, 2025	K243400	cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test	QOF	Substantially Equivalent	Roche Molecular Systems, Inc.	accessdata.fda.gov
April 11, 2025	K243346	cobas liat SARS-CoV-2 v2 nucleic acid test	QWR	Substantially Equivalent	Roche Molecular Systems, Inc.	accessdata.fda.gov
January 17, 2025	K240217	cobas® liat CT/NG nucleic acid test	QEP	Substantially Equivalent	Roche Molecular Systems, Inc.	accessdata.fda.gov
January 16, 2025	K240197	cobas® liat CT/NG/MG nucleic acid test	QEP	Substantially Equivalent	Roche Molecular Systems, Inc.	accessdata.fda.gov
December 4, 2023	K223783	cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System	QWR	Substantially Equivalent	Roche Molecular Systems, Inc.	accessdata.fda.gov
July 27, 2023	K223591	cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System	QOF	Substantially Equivalent	Roche Molecular Systems, Inc.	accessdata.fda.gov
November 4, 2022	K221007	cobas HCV	MZP	Substantially Equivalent	Roche Molecular Systems, Inc.	accessdata.fda.gov
October 22, 2022	K213804	cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems	QQX	Substantially Equivalent	Roche Molecular Systems, Inc.	accessdata.fda.gov
January 29, 2021	K203220	cobas BKV	QLX	Substantially Equivalent	Roche Molecular Systems, Inc.	accessdata.fda.gov
September 2, 2020	K202215	cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit	QMI	Substantially Equivalent	Roche Molecular Systems, Inc.	accessdata.fda.gov
July 30, 2020	DEN200015	cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit	QLX	Unknown	Roche Molecular Systems, Inc.	accessdata.fda.gov
December 5, 2019	DEN190016	cobas vivoDx MRSA	QIV	Unknown	Roche Molecular Systems, Inc.	accessdata.fda.gov
May 22, 2019	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	Roche Molecular Systems, Inc.	accessdata.fda.gov
March 21, 2018	K173887	cobas CT/NG for use on cobas 6800/8800 systems	LSL	Substantially Equivalent	Roche Molecular Systems, Inc.	accessdata.fda.gov
January 12, 2018	K172913	cobas Factor II and Factor V Test	NPR	Substantially Equivalent	Roche Molecular Systems, Inc.	accessdata.fda.gov
September 12, 2017	K171770	cobas Cdiff Nucleic acid test for use on the cobas Liat System	OZN	Substantially Equivalent	Roche Molecular Systems, Inc.	accessdata.fda.gov
February 9, 2017	K163184	cobas® CT/NG v2.0 Test	LSL	Substantially Equivalent	Roche Molecular Systems, Inc.	accessdata.fda.gov
July 25, 2016	K153544	cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System	OCC	Substantially Equivalent	Iquum, Inc.	accessdata.fda.gov
June 1, 2015	K150617	cobas HSV 1 and 2 Test	OQO	Substantially Equivalent	Roche Molecular Systems, Inc.	accessdata.fda.gov
May 20, 2015	K142422	cobas Cdiff Test	OZN	Substantially Equivalent	Roche Molecular Systems, Inc.	accessdata.fda.gov
December 17, 2014	K142721	cobas MRSA/SA Test	NQX	Substantially Equivalent	Roche Molecular Systems, Inc.	accessdata.fda.gov
November 4, 2014	K141338	LIAT STREP A ASSAY	PGX	Substantially Equivalent	Iquum, Inc.	accessdata.fda.gov
May 5, 2014	K140887	COBAS CT/NG V2.0 TEST	LSL	Substantially Equivalent	Roche Molecular Systems, Inc.	accessdata.fda.gov
December 2, 2013	K132270	COBAS CT/NG V2.0 TEST	LSL	Substantially Equivalent	Roche Molecular Systems, Inc.	accessdata.fda.gov
January 24, 2012	K110923	COBAS 4800 CT / NG TEST	MKZ	Substantially Equivalent	Roche Molecular Systems, Inc.	accessdata.fda.gov
August 4, 2011	K111387	LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER	OCC	Substantially Equivalent	Iquum, Inc.	accessdata.fda.gov
July 6, 2010	K091409	LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727	NQX	Substantially Equivalent	Roche Molecular Systems, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
June 18, 2020	P200014	cobas® EZH2 Mutation Test	OWD	10	March 17, 2026	accessdata.fda.gov
April 3, 2020	P190028	cobas HPV for use on the cobas 6800/8800 Systems	MAQ	25	June 16, 2026	accessdata.fda.gov
June 1, 2017	P160041	COBAS CMV	PAB	46	October 10, 2024	accessdata.fda.gov
June 1, 2016	P150047	cobas EGFR MUTATION TEST v2	OWD	2	October 19, 2016	accessdata.fda.gov
October 14, 2015	P150015	COBAS HCV TEST	MZP	42	June 2, 2021	accessdata.fda.gov
October 14, 2015	P150014	COBAS HBV TEST	MKT	57	October 17, 2025	accessdata.fda.gov
May 7, 2015	P140023	COBAS KRAS MUTATION TEST	OWD	32	March 17, 2026	accessdata.fda.gov
May 14, 2013	P120019	COBAS EGFR MUTATION TEST	OWD	41	March 17, 2026	accessdata.fda.gov
July 5, 2012	P110037	COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)	PAB	64	October 4, 2024	accessdata.fda.gov
August 17, 2011	P110020	COBAS 4800 BRAF V600 MUTATION TEST	OWD	44	March 17, 2026	accessdata.fda.gov
April 19, 2011	P100020	COBAS HPV TEST	MAQ	64	March 17, 2026	accessdata.fda.gov
October 30, 2008	P060030	COBAS AMPLIPREP/COBAS TAQMAN HCV TEST	MZP	83	August 11, 2021	accessdata.fda.gov
September 4, 2008	P050028	COBAS TAQMAN HBV TEST	MKT	88	October 4, 2024	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
December 21, 2022	91482	Class II	Ongoing	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.	accessdata.fda.gov
September 8, 2022	90885	Class II	Terminated	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.	accessdata.fda.gov
November 16, 2021	89643	Class II	Ongoing	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.	accessdata.fda.gov
September 3, 2021	88607	Class II	Ongoing	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	accessdata.fda.gov
August 4, 2021	88600	Class II	Terminated	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.	accessdata.fda.gov
March 25, 2021	87622	Class II	Ongoing	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	accessdata.fda.gov
November 23, 2020	86996	Class II	Terminated	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.	accessdata.fda.gov
November 19, 2020	86879	Class II	Terminated	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 screenin	Dirty Lens May Cause Invalid or False Positive Results	accessdata.fda.gov
June 3, 2020	85838	Class II	Terminated	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	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.	accessdata.fda.gov
May 2, 2018	79899	Class II	Terminated	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 mul	Cross-contamination of samples has been reported when running the existing protocol on the system with the rack-based purification run.	accessdata.fda.gov
October 27, 2017	79375	Class II	Terminated	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 a	accessdata.fda.gov
November 16, 2016	75786	Class II	Terminated	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 clini	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.	accessdata.fda.gov
May 17, 2016	74154	Class III	Terminated	cobas Liat Influenza A/B Quality Control Kit; For use with cobas Liat Influenza A/B Assay.	Kit labeled with the incorrect expiration date.	accessdata.fda.gov
May 9, 2016	74094	Class II	Terminated	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.	accessdata.fda.gov
April 5, 2016	74221	Class II	Terminated	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 dete	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.	accessdata.fda.gov
March 15, 2016	73703	Class II	Terminated	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).	accessdata.fda.gov
March 3, 2016	73680	Class II	Terminated	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.	accessdata.fda.gov
July 24, 2015	71785	Class II	Terminated	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.	accessdata.fda.gov
January 13, 2015	70355	Class III	Terminated	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.	accessdata.fda.gov
December 18, 2014	70058	Class III	Terminated	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 colorec	cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator.	accessdata.fda.gov
January 6, 2014	67441	Class II	Terminated	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	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.	accessdata.fda.gov
July 25, 2013	66036	Class II	Terminated	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 i	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 weigh	accessdata.fda.gov
April 1, 2013	64930	Class II	Terminated	cobas 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.	In rare instances, channel shifted results have been generated with cobas 4800 assays run on v1.1.1 of the cobas 4800 system. Raw data review indicates that, in these cases, all signals are shifted by one channel: channel 1 results report as channel 2, channel 2 results report as channel 3, channel 3 results report as channel 4, and channel 4 results report	accessdata.fda.gov
November 28, 2012	63997	Class II	Terminated	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 AMPLILINK software version 3.3 series and COBAS TaqMan MTB Test Kits, both CE-IVD and JPN-IVD, have an incorrect Target Elbow Max cutoff value of 48 creating the potential for false negative results to be generated for patient samples with Target Elbows	accessdata.fda.gov
October 11, 2012	63814	Class II	Terminated	COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM. Roche Molecular Systems, Inc. 1080 US Highway 202 South Branchburg, NJ 08876 USA	Certain COBAS AmpliPrep instruments using AMPILINK software v.3.3.4 had the sample clot detection flagging feature disabled during quality control release resulting in samples that may not be flagged as having clots.	accessdata.fda.gov
July 31, 2012	63310	Class III	Terminated	cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc., Product Usage: The primary use of the cobas 4800 BRAF V600 Mutation Test is the detection of the BRAF V600 mutations in DNA ex	It was identified that BRAF controls dispositioned as "Internal Use Only" were incorrectly packaged into cobas 4800 BRAF V600 Mutation Test CE-IVD kit lot R03607 and released for distribution. Two control batches manufactured during two process validation studies are involved: PV7711: BRAF Mutant (MUT) Control PV0853: BRAF Wild Type (WT) Control	accessdata.fda.gov
July 16, 2012	63312	Class II	Terminated	Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS AmpliPrep instrument, COBAS TaqMan analyzer, COBAS TaqMan 48 analyzer, COBAS AMPLICOR analyzer, and Cobas p 630 in	Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.	accessdata.fda.gov
April 23, 2012	62738	Class II	Terminated	Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System.	When using a Laboratory Information system (LIS) with automated systems utilizing AMPLILINK software v3.2 series (AL v3.2) there is a potential for wrong results to be assigned to an order.	accessdata.fda.gov
February 24, 2012	62500	Class III	Terminated	Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The Cobas KRAS Mutation Test, for use with the Cobas 4800 System, is a real-time PCR test intended for the identification of mutations in codons	During the real-time stability testing for the cobas KRAS Mutation Test on the commercial lot PO6778, it was identified that the kit was just within specifications for the codon 61 peak height ratio, and that the kit has trended towards the upper specification limit at the 6 month time point but did passed the 6 month stability testing. The kit is labeled fo	accessdata.fda.gov
February 1, 2012	62586	Class II	Terminated	COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold sample input tubes in the COBAS AmpliPrep Instrument (CAP) sample racks and have a barcode to identify the samp	Certain lots of COBAS AmpliPrep (CAP) S-tube Input (Box of 12 bags 12x24 S-tube and 12x24 S-clip) can cause the sample input tubes to stick in the barcode clips. As a consequence, the CAP instrument will lift both the sample input tube together with the barcode clip from the sample rack, resulting in an aborted run. No erroneous results would be produced if	accessdata.fda.gov
April 14, 2011	58784	Not yet classified	Terminated	COBAS AmpliPrep / COBAS TaqMan HCV Test, US-IVD The COBAS AmpliPrep/COBAS TaqMan HCV Test is an in vitro nucleic acid amplification test for the quantitation of Hepatitis C viral (HCV) RNA in human plasma or serum of HCV	The COBAS Ampliprep/COBAS TaqMan HCV Test has been shown to under-quantitate a subset of genotype 4 patient specimens by approximately 1.0-1.5 log 10 in the absence of any sequence mismatches.	accessdata.fda.gov
March 31, 2011	58747	Not yet classified	Terminated	Factor II (Prothrombin) G20210A Kit Light Cycler Instrument; Manufactured in Germany for Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA DisFor use with Light Cycler 2.0 instrument; The Factor II (Prothrombin) G20	Roche Molecular Systems has decided to discontinue marketing the Factor II (Prothrombin) G20210A Kit and the Factor V Leiden Kit for use with the Light Cycler 2.0 Instrument in the US Market	accessdata.fda.gov
December 28, 2010	57560	Not yet classified	Terminated	COBAS AmpliPrep/COBAS TaqMan HBV v2.0 US-IVD; COBAS AmpliPrep/COBAS TaqMan HBV v2.0 CE-IVD	There is an issue regarding liquid level detection of the CS1 Magnetic Glass Particles (MGP) Reagent Cassette of the COBAS AmpliPrep /COBAS TaqMan HBV v2.0 Test on the COBAS AmpliPrep instrument.	accessdata.fda.gov
June 2, 2009	52118	Not yet classified	Terminated	AMPLILINK Software, version 3.1.0 to 3.2.2 with COBAS AmpliPrep. Catalog number 03563383001, catalog number 04855094001, catalog number 04807197001, catalog number 04862392001, catalog number 05093236001, and catalog num	Software bug: A unique series of events involving the COBAS AmpliPrep instrument running AMPLILINK software version 3.2.2 that results in specimens being amplified and detected with the wrong parameters. The error can occur on either COBAS AmpliPrep/COBAS TaqMan 48, COBAS AmpliPrep/COBAS TaqMan (docked) or cobas s 201 system (docked) running Amplilink Softwa	accessdata.fda.gov
March 12, 2009	53708	Not yet classified	Terminated	FACTOR II (PROTHROMBIN) G20210A Kit, LightCycler 2.0 Instrument. Material Number 03610195 001 Cont. 1 FIIG20210A MD Mix, 1 x 78 uL 2. FIIG20210A R mix, 1 x 78 uL 3. FIIG20210A CT, 1 x 50 uL 5, FIIG20210A DIL 1 x 1 mL Man	Within the Precautions and Warning Section, Polymorphism heading, of the Product's Package Insert, it stated that mutations at positions 20207, 20209, 20218 and 20221 exist and these mutations are spanned by the mutation probe. These rare mutations will lead to an unknown result after performing genotyping.	accessdata.fda.gov
May 21, 2007	37963	Not yet classified	Terminated	Amplilink Software versions 1.1, 1.3, 1.4, 2.41. COBAS Amplicor CTA & NGA Tests	For select COBAS AMPLICOR Tests run on the COBAS AMPLICOR Analyzer in conjunction with AMPLILINK software, a discrepancy has been identified between the onboard working reagent stability information reported by AMPLILINK Software (versions 1.1, 1.3, 1.4 and 2.41) and the stability information provided in the test kit package inserts/method manual.	accessdata.fda.gov
March 9, 2007	37585	Not yet classified	Terminated	AmpliChip CYP450 Test-US IVD-M/N: 4591402190, Roche Molecular Diagnostics	The current package insert for the AmpliChip CYP 450 test, lists an incorrect part number for DNase I. The DNase is listed in the "Other Materials Required" section as 'DNase I rec., RNase-free, P/N 04716728001 (Roche Applied Science)". The Part Number listed for the DNase I listed is incorrect and of lower specific activity than the correct/validated DNase.	accessdata.fda.gov
February 14, 2005	31161	Not yet classified	Terminated	TaqMan HBV Analyte Specific Reagent, Material Number 3322092018, containing HBV Quantitation Standard (HBV QS).	Low level of recombinant HIV DNA found in one lot of HBV QS which is a component of one lot of the TaqMan HBV ASR.	accessdata.fda.gov

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Updated July 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.