Chrysalis Intelligence · Sponsors · Roche Molecular Systems, Inc.

Roche Molecular Systems, Inc.

Pleasanton, CA, US · 29 510(k) clearances · 143 PMAs · 12 recalls

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Total clearances
29
2020-02-10 → 2026-07-16
Last 12 months
7
Product codes
13
Most recent
2026-07-16
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
QEP — — — 6 2026-07-08
QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents Class II Microbiology 4 2025-07-31
QQX Respiratory Specimen Nucleic Acid Sars-Cov-2 Test Class II Microbiology 3 2025-02-11
OCC Respiratory Virus Panel Nucleic Acid Assay System Class II Microbiology 3 2022-07-06
MZP — — — 2 2025-11-03
QWR Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings Class II Microbiology 2 2025-04-11
OZN C. Difficile Toxin Gene Amplification Assay Class II Microbiology 2 2021-10-20
QLX Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna Class II Microbiology 2 2021-01-29
PQA — — — 1 2026-07-16
OZZ Bordetella Pertussis Dna Assay System Class II Microbiology 1 2025-11-20
PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Class II Microbiology 1 2025-11-03
QIH Automated Radiological Image Processing Software Class II Radiology 1 2025-05-30
QMI Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna Class II Microbiology 1 2020-09-02
Class III

PMA approvals (143)

Total PMA records
143
Originals + supplements
Distinct product codes
6
First decision
2020-02-06
Most recent
2026-06-16
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-06-16 P190028-S023 cobas HPV Normal 180 Day Track MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2026-04-23 P190028-S024 cobas® HPV Real-Time Process MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2026-03-17 P190028-S025 cobas® HPV 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2026-03-17 P140023-S032 cobas® KRAS Mutation Test 30-Day Notice OWD — —
2026-03-17 P110020-S044 cobas® BRAF V600 Mutation Test 30-Day Notice OWD — —
2026-03-17 P100020-S065 cobas® HPV 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2025-12-31 P190028-S022 cobas® HPV 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2025-12-31 P140023-S031 cobas® KRAS Mutation Test 30-Day Notice OWD — —
2025-12-31 P110020-S043 cobsa® BRAF V600 Mutation Test 30-Day Notice OWD — —
2025-12-31 P100020-S064 cobas® HPV 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2025-12-15 P100020-S063 COBAS HPV TEST 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2025-10-17 P150014-S056 cobas® HBV Normal 180 Day Track MKT Hepatitis Viral B Dna Detection Microbiology
2025-09-19 P190028-S021 cobas HPV Special (Immediate Track) MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2025-09-19 P150014-S058 cobas HBV Special (Immediate Track) MKT Hepatitis Viral B Dna Detection Microbiology
2025-08-07 P190028-S020 cobas® HPV 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2025-08-07 P150014-S057 cobas® HBV 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2025-03-27 P190028-S019 cobas HPV for use on the cobas 6800/8800 Systems Normal 180 Day Track No User Fee MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2025-03-27 P100020-S062 cobas HPV TEST Normal 180 Day Track No User Fee MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2024-10-10 P160041-S045 COBAS CMV 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2024-10-04 P190028-S017 cobas HPV 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2024-10-04 P160041-S043 cobas CMV 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2024-10-04 P150014-S052 cobas HBV 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2024-10-04 P110037-S064 COBAS AmpliPrep/COBAS TaqMan CMV Test 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2024-10-04 P050028-S094 COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2024-10-02 P160041-S044 cobas CMV 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2024-10-02 P150014-S053 cobas HBV 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2024-09-27 P190028-S018 cobas® HPV 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2024-09-27 P160041-S046 cobas® CMV 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2024-09-27 P150014-S055 cobas® HBV 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2024-09-11 P190028-S016 cobas HPV 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2024-09-11 P160041-S042 cobas CMV 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2024-09-11 P150014-S051 cobas HBV 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2024-09-11 P110037-S063 COBAS AmpliPrep/COBAS TaqMan CMV Test 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2024-09-11 P050028-S093 COBAS AmpliPrep/ COBAS TaqMan HBV Test, v 2.0 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2024-08-14 P100020-S061 cobas HPV Test Special (Immediate Track) MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2024-07-01 P190028-S015 cobas HPV 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2024-07-01 P160041-S041 cobas CMV 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2024-07-01 P150014-S050 Roche cobas HBV 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2024-06-14 P100020-S060 cobas® HPV Test Special (Immediate Track) MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2024-05-15 P140023-S030 Roche cobas KRAS Mutation Test, Roche cobas® DNA Sample Preparation Kit Special (Immediate Track) OWD — —
2024-05-14 P190028-S009 cobas HPV Panel Track MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2024-05-14 P100020-S055 cobas HPV Test Panel Track MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2024-04-11 P140023-S029 Roche cobas DNA Sample Preparation Kit 30-Day Notice OWD — —
2024-04-11 P110020-S042 Roche cobas 4800 BRAF V600 Mutation Test 30-Day Notice OWD — —
2024-02-23 P110037-S062 COBAS® AmpliPrep®, COBAS® TaqMan® CMV Test 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2024-02-23 P100020-S059 cobas® HPV 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2024-02-23 P050028-S092 COBAS® AmpliPrep®, COBAS® TaqMan® HBV Test, v2.0 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2024-01-18 P150014-S049 cobas® HBV 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2023-12-21 P140023-S028 Roche cobas KRAS Mutation Test Special (Immediate Track) OWD — —
2023-12-21 P110020-S041 Roche cobas BRAF V600 Mutation Test Special (Immediate Track) OWD — —
2023-12-14 P190028-S014 cobas® HPV 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2023-12-14 P190028-S013 cobas HPV 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2023-12-14 P160041-S040 cobas® CMV 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2023-12-14 P160041-S039 cobas® CMV 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2023-12-14 P150014-S048 cobas® HBV 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2023-12-14 P150014-S047 cobas® HBV 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2023-12-14 P140023-S027 cobas® KRAS Mutation Test 30-Day Notice OWD — —
2023-12-14 P110037-S061 COBAS® AmpliPrep® / COBAS® TaqMan® CMV Test 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2023-12-14 P110037-S060 COBAS® AmpliPrep® / COBAS® TaqMan® CMV Test 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2023-12-14 P110020-S040 cobas® BRAF V600 Mutation Test 30-Day Notice OWD — —
2023-12-14 P100020-S058 cobas® HPV 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2023-12-14 P050028-S091 COBAS® AmpliPrep® / COBAS® TaqMan® HBV Test, v2.0 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2023-12-14 P050028-S089 COBAS® AmpliPrep® / COBAS® TaqMan® HBV Test, v2.0 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2023-10-04 P190028-S007 cobas® HPV Normal 180 Day Track MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2023-08-23 P190028-S012 cobas® HPV 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2023-08-23 P160041-S038 cobas® CMV 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2023-08-23 P150014-S046 cobas® HBV 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2023-08-23 P110037-S059 COBAS® AmpliPrep/COBAS® TaqMan® CMV Test 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2023-08-23 P110020-S039 cobas® 4800 BRAF V600 Mutation Test 30-Day Notice OWD — —
2023-08-23 P100020-S057 cobas® 4800 HPV Test 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2023-08-23 P050028-S088 COBAS® AmpliPrep/COBAS® TaqMan® HBV Test 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2023-08-17 P190028-S010 cobas® HPV 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2023-08-17 P160041-S036 cobas® CMV 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2023-08-17 P150014-S044 cobas® HBV 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2023-08-17 P140023-S026 Roche cobas® KRAS Mutation Test, Roche cobas® DNA Sample Preparation Kit 30-Day Notice OWD — —
2023-08-17 P110037-S058 COBAS® AmpliPrep, COBAS® TaqMan® CMV Test 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2023-08-17 P110020-S038 Roche cobas DNA Sample Preparation Kit, Roche cobas 4800 BRAF V600 Mutation Test 30-Day Notice OWD — —
2023-08-17 P100020-S056 cobas HPV Test, 240 Tests, cobas HPV Test, 960 Tests 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2023-08-17 P050028-S087 COBAS® AmpliPrep, COBAS® TaqMan® HBV Test, v2.0 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2023-08-16 P190028-S011 cobas® HPV 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2023-08-16 P160041-S037 cobas® CMV 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2023-08-16 P150014-S045 cobas® HBV 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2023-05-16 P190028-S008 cobas® HPV Real-Time Process MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2023-02-23 P150014-S043 cobas® HBV Normal 180 Day Track MKT Hepatitis Viral B Dna Detection Microbiology
2022-12-14 P160041-S035 cobas CMV Normal 180 Day Track PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2022-11-29 P140023-S024 cobas® KRAS Mutation Test 30-Day Notice — — —
2022-11-29 P110020-S036 cobas® BRAF V600 Mutation Test 30-Day Notice OWD — —
2022-11-14 P140023-S025 cobas® KRAS Mutation Test 30-Day Notice OWD — —
2022-11-14 P110037-S057 COBAS® AmpliPrep/ COBAS® TaqMan® CMV Test 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2022-11-14 P110020-S037 cobas® BRAF V600 Mutation Test 30-Day Notice OWD — —
2022-11-14 P100020-S054 cobas® HPV 30-Day Notice — — —
2022-11-14 P050028-S086 COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test, v2.0 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2022-01-19 P190028-S006 Cobas HPV 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2022-01-19 P160041-S034 Cobas CMV 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2022-01-19 P150014-S042 Roche Cobas HBV 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2021-08-11 P110037-S056 COBAS AmpliPrep/COBAS TaqMan CMV Test 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2021-08-11 P060030-S086 COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0 30-Day Notice MZP — —
2021-08-11 P050028-S085 COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2021-06-02 P190028-S005 cobas HPV Special (Immediate Track) MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2021-06-02 P160041-S033 cobas CMV Special (Immediate Track) PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2021-06-02 P150015-S043 cobas HCV Special (Immediate Track) MZP — —
2021-06-02 P150014-S041 cobas HBV Special (Immediate Track) MKT Hepatitis Viral B Dna Detection Microbiology
2021-03-09 P110037-S055 COBAS AmpliPrep/COBAS TaqMan CMV Test 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2021-03-09 P060030-S085 COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0 30-Day Notice MZP — —
2021-03-09 P050028-S084 COBAS AmpliPrep/COBAS TaqMan HBV Test, V2.0 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2020-12-10 P190028-S004 cobas HPV 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2020-12-10 P160041-S032 cobas CMV 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2020-12-10 P150015-S042 cobas HCV 30-Day Notice MZP — —
2020-12-10 P150014-S040 cobas HBV 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2020-11-02 P150015-S039 cobas HCV Real-Time Process MZP — —
2020-11-02 P150014-S037 cobas HBV Real-Time Process MKT Hepatitis Viral B Dna Detection Microbiology
2020-10-07 P190028-S003 cobas HPV Special (Immediate Track) MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2020-10-07 P160041-S031 cobas CMV Special (Immediate Track) PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2020-10-07 P150015-S041 cobas HCV Special (Immediate Track) MZP — —
2020-10-07 P150014-S039 cobas HBV Special (Immediate Track) MKT Hepatitis Viral B Dna Detection Microbiology
2020-08-26 P190028-S002 cobas HPV Test 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2020-08-26 P160041-S030 cobas CMV 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2020-08-26 P150015-S040 cobas HCV 30-Day Notice MZP — —
2020-08-26 P150014-S038 cobas HBV 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2020-08-26 P140023-S023 cobas KRAS Mutation Test 30-Day Notice OWD — —
2020-08-26 P110037-S054 COBAS AmpliPrep/COBAS TaqMan CMV Test 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2020-08-26 P110020-S035 cobas BRAF V600 Mutation Test 30-Day Notice OWD — —
2020-08-26 P100020-S053 cobas 4800 HPV Test 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2020-08-26 P060030-S084 COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 30-Day Notice MZP — —
2020-08-26 P050028-S083 Roche COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2020-06-24 P100020-S052 cobas HPV Mg/Mn 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2020-05-18 P140023-S022 cobas KRAS Mutation Test Real-Time Process OWD — —
2020-05-14 P160041-S029 cobas CMV 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2020-05-14 P150015-S038 cobas HCV 30-Day Notice MZP — —
2020-05-14 P150014-S036 cobas HBV 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2020-05-14 P110037-S053 COBAS AmpliPrep/COBAS TaqMan CMV Test 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2020-05-14 P100020-S051 cobas HPV Test 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2020-05-14 P060030-S083 COBAS® TaqMan® HCV Test, v2.0, for Use with the High Pure System and COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test, v2.0 30-Day Notice MZP — —
2020-05-14 P050028-S082 COBAS® TaqMan® HBV Test for Use with the High Pure System and COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test, v2.0 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2020-05-05 P190028-S001 cobas HPV 30-Day Notice MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2020-04-03 P190028 cobas HPV for use on the cobas 6800/8800 Systems Original MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2020-03-04 P100020-S049 cobas HPV Test Normal 180 Day Track MAQ Kit, Dna Detection, Human Papillomavirus Unknown
2020-02-20 P110037-S052 Cobas AmpliPrep/Cobas TaqMan CMV Test 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2020-02-20 P060030-S082 Cobas AmpliPrep/Cobas Taqman HCV Test v2.0 30-Day Notice MZP — —
2020-02-20 P050028-S081 Cobas AmpliPrep/Cobas TaqMan HBV Test, v2.0 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
2020-02-06 P160041-S028 cobas CMV 30-Day Notice PAB Cytomegalovirus (Cmv) Dna Quantitative Assay Microbiology
2020-02-06 P150015-S037 cobas HCV 30-Day Notice MZP — —
2020-02-06 P150014-S035 cobas HBV 30-Day Notice MKT Hepatitis Viral B Dna Detection Microbiology
Safety

Recalls (12)

Class I (serious)
0
Risk of injury / death
Total recalls
12
Currently ongoing
7
Most recent
2022-12-21
DateSeverityStatusRecall # ProductCodeReason
2022-12-21 Class II Ongoing Z-1106-2023 cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Mat… — 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 …
2022-12-21 Class II Ongoing Z-1105-2023 cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Num… — 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 …
2022-12-21 Class II Ongoing 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 …
2022-09-08 Class II Terminated Z-0097-2023 cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid T… — Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses.
2021-11-16 Class II Ongoing 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 detecto…
2021-09-03 Class II Ongoing 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
2021-08-04 Class II Terminated 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.
2021-03-25 Class II Ongoing 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 em…
2021-03-25 Class II Ongoing Z-1413-2021 cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Li… — 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 em…
2020-11-23 Class II Terminated 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 measure…
2020-11-19 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… — Dirty Lens May Cause Invalid or False Positive Results
2020-06-03 Class II Terminated Z-2551-2020 MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 - Product Usage: This protocol is i… — 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-…
Filings

All 510(k) clearances (29)

Date K-number Device Code Class Specialty
2026-07-16 K260021 cobas® BV/CV PQA — —
2026-07-08 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 — —
2026-05-15 K253759 cobas liat CT/NG/MG nucleic acid test QEP — —
2026-05-15 K253756 cobas liat CT/NG nucleic acid test QEP — —
2025-11-20 K243753 cobas liat Bordetella panel nucleic acid test OZZ Class II Microbiology
2025-11-03 K252484 cobas HCV MZP — —
2025-11-03 K252481 cobas CMV PAB Class II Microbiology
2025-07-31 K243455 cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems QOF Class II Microbiology
2025-05-30 K243863 Opulus™ Lymphoma Precision QIH Class II Radiology
2025-04-25 K243406 cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test QOF Class II Microbiology
2025-04-25 K243400 cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test QOF Class II Microbiology
2025-04-11 K243346 cobas liat SARS-CoV-2 v2 nucleic acid test QWR Class II Microbiology
2025-02-11 K240867 cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems QQX Class II Microbiology
2025-01-17 K240217 cobas® liat CT/NG nucleic acid test QEP — —
2025-01-16 K240197 cobas® liat CT/NG/MG nucleic acid test QEP — —
2023-12-04 K223783 cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System QWR Class II Microbiology
2023-07-27 K223591 cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System QOF Class II Microbiology
2023-06-01 K231306 cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems QQX Class II Microbiology
2022-11-04 K221007 cobas HCV MZP — —
2022-10-22 K213804 cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems QQX Class II Microbiology
2022-07-06 K213822 cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System OCC Class II Microbiology
2021-10-20 K212427 cobas Cdiff nucleic acid test for use on the cobas Liat System OZN Class II Microbiology
2021-09-09 K210385 cobas Cdiff nucleic acid test for use on the cobas Liat System OZN Class II Microbiology
2021-02-16 K210234 cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System OCC Class II Microbiology
2021-01-29 K203220 cobas BKV QLX Class II Microbiology
2021-01-21 K202408 cobas CTNG for use on cobas 6800/8800 systems QEP — —
2020-09-02 K202215 cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit QMI Class II Microbiology
2020-07-30 DEN200015 cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit QLX Class II Microbiology
2020-02-10 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 Class II Microbiology
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence