Is this your brand? Sign in to claim ownership.

Roche Molecular System, Inc.

Last updated May 23, 2026

Information

Country: US
Address: —
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: —

Catalogue (212)

Page 4 of 5

Device	Model / Reference	Registries	Class	Status
cobas® CT/NG v2.0 Test	K163184	FDA 510(k)	Class II	Active
cobas Factor II and Factor V Test	K172913	FDA 510(k)	Class II	Active
cobas® liat CT/NG nucleic acid test	K240217	FDA 510(k)	Class II	Active
Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System	K191729	FDA 510(k)	Class II	Active
cobas vivoDx MRSA	DEN190016	FDA 510(k)	Class II	Active
cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System	K223591	FDA 510(k)	Class II	Active
cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test	K243400	FDA 510(k)	Class II	Active
cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit	K190433	FDA 510(k)	Class II	Active
cobas Cdiff nucleic acid test for use on the cobas Liat System	K210385	FDA 510(k)	Class II	Active
Cobas Ct/Ng V2.0 Test	K140887	FDA 510(k)	Class II	Active
cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit	K202215	FDA 510(k)	Class II	Active
Opulus™ Lymphoma Precision	K243863	FDA 510(k)	Class II	Active
Cobas 4800 Ct / Ng Test	K110923	FDA 510(k)	Class I	Active
cobas CTNG for use on cobas 6800/8800 systems	K202408	FDA 510(k)	Class II	Active
Amplicor Chlamydia Trachomatis Test	K922906	FDA 510(k)	Class I	Active
cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System	K210234	FDA 510(k)	Class II	Active
cobas BKV	K203220	FDA 510(k)	Class II	Active
cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System	K223783	FDA 510(k)	Class II	Active
cobas MRSA/SA Test	K142721	FDA 510(k)	Class II	Active
cobas Cdiff nucleic acid test for use on the cobas Liat System	K212427	FDA 510(k)	Class II	Active
cobas® liat CT/NG/MG nucleic acid test	K240197	FDA 510(k)	Class II	Active
Roche Amplicor Ct/Ng Test For Neisseria Gonorrhoeae	K974503	FDA 510(k)	Class II	Active
cobas Cdiff Test	K142422	FDA 510(k)	Class II	Active
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	K200065	FDA 510(k)	Class II	Active
cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit	DEN200015	FDA 510(k)	Class II	Active
cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test	K243406	FDA 510(k)	Class II	Active
cobas CT/NG for use on cobas 6800/8800 systems	K173887	FDA 510(k)	Class II	Active
Roche Cobas Taqman Analyzer	K012966	FDA 510(k)	Class I	Active
cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems	K243455	FDA 510(k)	Class II	Active
cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems	K231306	FDA 510(k)	Class II	Active
cobas HSV 1 and 2 Test	K150617	FDA 510(k)	Class II	Active
Roche Cobas Amplicor Analyzer	K964506	FDA 510(k)	Class I	Active
cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems	K240867	FDA 510(k)	Class II	Active
Amplichip Cyp450 Test, Model 04381866190	DEN040011	FDA 510(k)	Class II	Active
cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System	K213822	FDA 510(k)	Class II	Active
Roche Cobas Amplicor Ct/Ng Test For Neisseria Gonorrhoeae	K974342	FDA 510(k)	Class II	Active
cobas liat SARS-CoV-2 v2 nucleic acid test	K243346	FDA 510(k)	Class II	Active
Cobas Ct/Ng V2.0 Test	K132270	FDA 510(k)	Class II	Active
Lightcycler Mrsa Advanced Test For Use With The Lightcycler 2.0 Instrument, Model 05205727	K091409	FDA 510(k)	Class II	Active
cobas Cdiff Nucleic acid test for use on the cobas Liat System	K171770	FDA 510(k)	Class II	Active
cobas liat Bordetella panel nucleic acid test	K243753	FDA 510(k)	Class II	Active
Roche Cobas Amplicor Ct/Ng Test For Chlamydia Trachomatis	K973718	FDA 510(k)	Class I	Active
Roche Amplicor Ct/Ng Test For Chlamydia Trachomatis	K973707	FDA 510(k)	Class I	Active
Roche Amplichip Cyp450 Test	K043576	FDA 510(k)	Class II	Active
Roche Cobas Amplicor Chlamydia Trachomatis Test	K964507	FDA 510(k)	Class I	Active
cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems	K213804	FDA 510(k)	Class II	Active
Cobas Egfr Mutation Test	P150047	FDA PMA	Class III	Active
cobas® EZH2 Mutation Test	P200014	FDA PMA	N/A	Active
cobas HPV	P190028	FDA PMA	Class III	Active
cobas EGFR MUTATION TEST v2	P150044	FDA PMA	Class III	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (66)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Dec 21, 2022	Z-1105-2023	—	open, classified	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.
Dec 21, 2022	Z-1106-2023	—	open, classified	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.
Dec 21, 2022	Z-1104-2023	—	open, classified	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.
Sep 8, 2022	Z-0097-2023	—	terminated	Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses.
Nov 16, 2021	Z-0828-2022	—	open, classified	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.
Sep 3, 2021	Z-0083-2022	—	open, classified	False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment
Aug 4, 2021	Z-2498-2021	—	terminated	Customers have reported an increased number of false positive SARS-CoV-2 results.
Mar 25, 2021	Z-1413-2021	—	open, classified	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
Mar 25, 2021	Z-1414-2021	—	open, classified	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
Nov 23, 2020	Z-0877-2021	—	terminated	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.
Nov 19, 2020	Z-0846-2021	—	terminated	Dirty Lens May Cause Invalid or False Positive Results
Jun 3, 2020	Z-2551-2020	—	terminated	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.
May 2, 2018	Z-1956-2018	—	terminated	Cross-contamination of samples has been reported when running the existing protocol on the system with the rack-based purification run.
Oct 27, 2017	Z-1195-2018	—	terminated	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.
Nov 16, 2016	Z-0750-2017	—	terminated	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.
May 17, 2016	Z-2203-2016	—	terminated	Kit labeled with the incorrect expiration date.
May 9, 2016	Z-2216-2016	—	terminated	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.
Apr 5, 2016	Z-2254-2016	—	terminated	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.
Mar 15, 2016	Z-1830-2016	—	terminated	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).
Mar 3, 2016	Z-1578-2016	—	terminated	The hand-held barcode scanner model IT3800 used with the COBAS AmpliPrep instrument mis-identified a sample barcode ID.
Jul 24, 2015	Z-2543-2015	—	terminated	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.
Jan 13, 2015	Z-1320-2015	—	terminated	False positive results for Exon 20 insertion mutations are being detected with the cobas EGFR Mutation Test, kit batch T08661.
Dec 18, 2014	Z-0999-2015	—	terminated	cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator.
Jan 6, 2014	Z-1111-2014	—	terminated	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.
Jul 25, 2013	Z-2173-2013	—	terminated	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
Apr 1, 2013	Z-1346-2013	—	terminated	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 as channel 1. In the reported
Nov 28, 2012	Z-0762-2013	—	terminated	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 in the range of 48 to 50.
Oct 11, 2012	Z-0614-2013	—	terminated	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.
Jul 31, 2012	Z-0188-2013	—	terminated	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
Jul 16, 2012	Z-0487-2013	—	terminated	Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Jul 16, 2012	Z-0491-2013	—	terminated	Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Jul 16, 2012	Z-0485-2013	—	terminated	Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Jul 16, 2012	Z-0492-2013	—	terminated	Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Jul 16, 2012	Z-0486-2013	—	terminated	Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Jul 16, 2012	Z-0489-2013	—	terminated	Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Jul 16, 2012	Z-0490-2013	—	terminated	Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Jul 16, 2012	Z-0488-2013	—	terminated	Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Jul 16, 2012	Z-0484-2013	—	terminated	Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Jul 16, 2012	Z-0493-2013	—	terminated	Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Apr 23, 2012	Z-2403-2012	—	terminated	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.
Feb 24, 2012	Z-2159-2012	—	terminated	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 for 9 months shelf life stability. The d
Feb 1, 2012	Z-2209-2012	—	terminated	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 the issue occurs, but samples in proce
Apr 14, 2011	Z-2586-2011	—	terminated	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.
Apr 14, 2011	Z-2587-2011	—	terminated	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.
Mar 31, 2011	Z-2566-2011	—	terminated	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
Mar 31, 2011	Z-2565-2011	—	terminated	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
Dec 28, 2010	Z-1459-2011	—	terminated	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.
Jun 2, 2009	Z-1928-2009	—	terminated	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 Software versions 3.1 or 3.2 series up to and
Mar 12, 2009	Z1006-2010	—	terminated	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.
May 21, 2007	Z-1106-2007	—	terminated	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.
May 21, 2007	Z-1107-2007	—	terminated	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.
Mar 9, 2007	Z-0734-2007	—	terminated	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.
Mar 9, 2007	Z-0735-2007	—	terminated	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.
Feb 14, 2005	Z-0983-05	—	terminated	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.
Jul 7, 2004	Z-1364-04	—	terminated	An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection.
Jul 7, 2004	Z-1363-04	—	terminated	An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection.
Jul 7, 2004	Z-1367-04	—	terminated	An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection.
Jul 7, 2004	Z-1362-04	—	terminated	An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection.
Jul 7, 2004	Z-1368-04	—	terminated	An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection.
Jul 7, 2004	Z-1366-04	—	terminated	An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection.
Jul 7, 2004	Z-1365-04	—	terminated	An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection.
Jul 7, 2004	Z-1361-04	—	terminated	An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection.
Jul 7, 2004	Z-1360-04	—	terminated	An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection.
May 24, 2004	Z-1120-04	—	terminated	Improper seating of a fiber optic cable which may cause pixel cross-talk leading to falsely elevated test results or cases of misalignment to sample-to-result mismatch.
May 24, 2004	Z-1119-04	—	terminated	Improper seating of a fiber optic cable which may cause pixel cross-talk leading to falsely elevated test results or cases of misalignment to sample-to-result mismatch.
Mar 6, 2003	Z-0917-03	—	terminated	A false positive result may be reported.