Hepatitis Viral B Dna Detection
Microbiology · 21 CFR 866.3174
Nucleic acid assay for detection of Hepatitis B Virus (HBV) DNA is an in vitro nucleic acid assay for detection and quantitation of HBV DNA in human serum or plasma. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The test results must be interpreted within the context of all relevant clinical and laboratory findings.
Recent MDR events
45 adverse event reports on file
- COBAS® HBV (192T)Nov 14, 2025MalfunctionRoche Molecular Systems, Inc. - Branchburg2243471-2025-04642
- COBAS® HBV (192T)Oct 31, 2025MalfunctionRoche Molecular Systems, Inc. - Branchburg2243471-2025-04437
- COBAS® HBV (192T)Dec 11, 2024MalfunctionRoche Molecular Systems, Inc. - Branchburg2243471-2024-03608
- COBAS® HBV (192T)Nov 7, 2024MalfunctionRoche Molecular Systems, Inc. - Branchburg2243471-2024-03218
- COBAS® HBV (192T)Aug 30, 2023MalfunctionRoche Molecular Systems, Inc. - Branchburg2243471-2023-02824
- ALINITY M HBV AMP KITJul 28, 2023InjuryAbbott Molecular, Inc.3005248192-2023-00200
- COBAS® AMPLIPREP/COBAS® TAQMAN® HBV TEST, V2.0Aug 30, 2022MalfunctionRoche Molecular Systems, Inc.2243471-2022-00744
- ALINITY M HBV AMPLIFICATION KITMar 29, 2022MalfunctionAbbott Molecular, Inc.3005248192-2022-00527
- COBAS® HBVMar 6, 2019MalfunctionRoche Molecular Systems, Inc.2243471-2019-00009
- CAP/CTM HBV TEST, V2.0, CE-IVDOct 10, 2018MalfunctionRoche Molecular Systems, Inc.2243471-2018-00012
Event type breakdown
Recalls
7 recall events for this product code
- Abbott Molecular, Inc.Open, ClassifiedApr 6, 2022
Alinity m HBV Application Specification File (US and CE)
There is a potential for misquantitation high results of negative samples.
Z-0883-2022 · View FDA record ↗ - Abbott Molecular, Inc.Open, ClassifiedApr 6, 2022
Alinity m HBV AMP Kit (US and CE)
There is a potential for misquantitation high results for negative samples.
Z-0884-2022 · View FDA record ↗ - Roche Molecular Systems, Inc.TerminatedMar 1, 2011
COBAS AmpliPrep/COBAS TaqMan HBV v2.0 US-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.
Z-1459-2011 · View FDA record ↗ - Abbott MolecularTerminatedFeb 23, 2011
Abbott RealTime HBV Assay, List 2N40, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA
Internal testing identified the potential of under filled and over filled enzyme reagent vials which may result in obtaining less than the total number of tests per kit as described on the package insert.
Z-1399-2011 · View FDA record ↗ - Medtronic Emergency Response Systems, Inc.TerminatedAug 4, 2007
biphasic LIFEPAK 500 automated external defibrillators (AEDs) with software version 4.4 or lower; Part Nos. 3011790-XXXXXX, D3100790-XXXXXX, and U3011790-XXXXX
Reduced Shock- the device may deliver 100 Joule (J) to a patient, which is less than the recommended factory minimum default setting of 200 J.
Z-1148-2007 · View FDA record ↗ - Zoll Medical CorporationTerminatedSep 17, 2004
Zoll M Series Automated Defibrillator (AED)
Visual Sreen display and audible prompt may not advise to 'Press Shock'
Z-1472-04 · View FDA record ↗ - Roche Diagnostics Operations, Inc.TerminatedUnknown
cobas 6800/8800 system
Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process.
Z-0110-2017 · View FDA record ↗
Registered firms
16 firms currently registered for this product code
Abbott Molecular, Inc.
Des Plaines, IL, US
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Hologic, Inc.
SAN DIEGO, CA, US
Roche Diagnostics International Ltd.
ROTKREUZ Zug, CH
Roche Molecular Systems, Inc.
Branchburg, NJ, US
Abbott Molecular Distribution Center
Itasca, IL, US
Roche Molecular Systems, Inc.
PLEASANTON, CA, US
Karl Storz Endoscopy Canada Ltd.
Mississauga Ontario, CA
Rpi Biosolutions
Mundelein, IL, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.
PMA approvals
5 premarket approvals for this product code
- Abbott Molecular, Inc.Aug 29, 2020
P200013 · Alinity m HBV
- Hologic, Inc.Jan 23, 2018
P170025 · Aptima HBV Quant Assay
- Roche Molecular Systems, Inc.Oct 14, 2015
P150014 · COBAS HBV TEST
- Abbott Molecular, Inc.Aug 13, 2010
P080026 · ABBOTT REALTIME HBV ASSAY
- Roche Molecular Systems, Inc.Sep 4, 2008
P050028 · COBAS TAQMAN HBV TEST