Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA product code LOM · Class II (moderate risk) · 21 CFR 866.3172 · Microbiology
In vitro diagnostic device intended for aid in the diagnosis of chronic or acute HBV infection. HBV surface antigen (HbsAg) is also used for screening of HBV infection in pregnant women to identify neonates who are at risk of acquiring hepatitis B during perinatal period.
1510(k) clearances
25PMA approvals
30recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260770 | LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteXLOM · Traditional | DiaSorin, Inc. | 06/04/2026SE |
PMA approvals
- P230015 Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC · Beckman Coulter, Inc. · 10/17/2025
- P210003 ARCHITECT HBsAg Next Qualitative Reagent Kit, ARCHITECT HBsAg Next Confirmatory Reagent Kit, ARCHITECT HBsAg NEXT Qualit · Abbott Laboratories · 08/10/2022
- P190017 LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory Test · DiaSorin, Inc. · 08/29/2020
- P180048 LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg · DiaSorin, Inc. · 08/29/2020
- P160019 Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/ PreciControl HBsAg II · Roche Diagnostics, Inc. · 12/23/2016
- P110041 Advia Centaur Hbsagii · Siemens Corp. · 05/16/2014
- P130015 Elecsys® Hbeag Immunoassay and Elecsys® Precicontrol Hbeag · Roche Diagnostics Operations, Inc. · 03/14/2014
- P110029 Architect Hbsag Qualitative, Qualitative Confirmatory, Confirmatory Manual Diluent, Calibrators, and Controls · Abbott Laboratories · 04/12/2012
- P090024 Advia Centaur Hbeag Assay and Quality Control Material · Siemens Healthcare Diagnostics · 10/11/2011
- P090028 Vitros Immunodiagnostic Products Hbeag Reagent Pack/Products Hbeag Calibrator/Products Hbe Controls · Ortho-Clinical Diagnostics, Inc. · 05/11/2011
- P060012 Axsym Core 2.0 and Axsym Core 2.0 Controls · Abbott Laboratories, Inc. · 09/08/2006
- P060007 Architect Hbsag Reagent Kit, Calibrators, Controls, Confirmatory Reagent Kit, Confirmatory Manual Diluent · Abbott Laboratories · 09/07/2006
- P060009 Axsym Core-M 2.0 and Axsym Core-M 2.0 Controls · Abbott Laboratories, Inc. · 08/25/2006
- P060003 Axsym, Ausab · Abbott Laboratories, Inc. · 08/07/2006
- P050049 Axsym Hbsag, Hbsag Confirmatory, and Axsym Hbsag Controls · Abbott Laboratories, Inc. · 06/01/2006
- P030049 Advia Centaur Hbsag Ready Pack Reagents/Confirmatory Ready Pack Reagents/Quality Control Material · Siemens Healthcare Diagnostics · 05/26/2005
- P030029 Advia Centaur Anti-Hbs Readypack Reagents and Calibrators · Siemens Healthcare Diagnostics · 05/14/2004
- P010050 Immulite 2000 Xpi Hbsag · Siemens Healthcare Diagnostics Products, Ltd. · 07/26/2002
- P990012 Elecsys Hbsag Immunoassay, Elecsys Hbsag Confirmatory, and Precicontrol Hbsag · Roche Diagnostics Corp. · 06/01/2001
- P000044 Vitros Immunodiagnostic Products/Hbsag Reagent Pack,Vitros Immunodiagnostic Products Confirmatory Kit, and Vitros Immunr · Ortho-Clinical Diagnostics, Inc. · 04/27/2001
- P990038 Diasorin Eti MAK-2 Plus Assay · DiaSorin, Inc. · 03/30/2001
- P990043 Diasorin Eti-Ebk Plus Assay · DiaSorin, Inc. · 02/08/2001
- P870048 Ebk · Diasorin · 07/13/1990
- P840070 Hepanostika(Tm) Hbeag/Anti Hbe Microelisa(Tm) Syst · Organon Teknika Corp. · 05/14/1986
- P790025 Abbott Hbe Diagnostic Kit · Abbott Laboratories · 07/15/1980
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1847-2025 Class II | ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | Mckesson Medical-Surgical Inc. Corporate… | 04/24/2025Open, Classified |
| Z-1842-2025 Class II | ABBOTT DIAGNOSTICS ARCH AUSAB ANTI-HBS (100/EA) REAGENT.transit delays of certain cold chain products due to severe thunderstorms which may caused the products to… | Mckesson Medical-Surgical Inc. Corporate… | 04/24/2025Open, Classified |
| Z-2142-2024 Class II | VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator…Potential for positively biased results due to signal reduction over shelf life. | Ortho-Clinical Diagnostics, Inc. | 03/01/2024Open, Classified |
| Z-0772-2024 Class II | VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925…Affected lots may experience increased calibration failures or an increase in falsely elevated results. | Ortho-Clinical Diagnostics, Inc. | 11/27/2023Open, Classified |
| Z-1143-2023 Class II | ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic…Anti-HBe2 (aHBe2) interference with the Hepatitis B e Antigen (HBeAg) Assay, leads to elevated or reactive… | Siemens Healthcare Diagnostics, Inc. | 12/22/2022Open, Classified |
| Z-0688-2019 Class II | VITROS HBeAg Reagent, Cat. No 6801819 Product Usage: For the in vitro qualitative…The firm is extending their previous July 2018 recall to include additional product codes. Biased results… | Ortho-Clinical Diagnostics | 11/01/2018Open, Classified |
| Z-0687-2019 Class II | VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For the in vitro…The firm is extending their previous July 2018 recall to include additional product codes. Biased results… | Ortho-Clinical Diagnostics | 11/01/2018Open, Classified |
| Z-1690-2018 Class II | ADVIA Centaur HBc IgMConcentrations for the level of biotin that does not interfere is not currently listed in the instruction… | Siemens Healthcare Diagnostics, Inc. | 01/02/2018Terminated |
| Z-1675-2018 Class II | IMMULITE 2000/IMMULITE 2000 XPi Anti HBcConcentrations for the level of biotin that does not interfere is not currently listed in the instruction… | Siemens Healthcare Diagnostics, Inc. | 01/02/2018Terminated |
| Z-0103-2015 Class II | ADVIA Centaur Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. Catalog Number:…Increased imprecision and positive bias is observed with patient samples and negative controls and can… | Siemens Healthcare Diagnostics, Inc | 09/15/2014Terminated |
| Z-0102-2015 Class II | Siemens ADVIA Centaur Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic Use…Increased imprecision and positive bias is observed with patient samples and negative controls and can… | Siemens Healthcare Diagnostics, Inc | 09/15/2014Terminated |
| Z-0557-2014 Class II | VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent PacksOrtho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products… | Ortho-Clinical Diagnostics | 10/25/2013Terminated |
| Z-0032-2014 Class III | FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade…The FSE Image Upgrade kit (part 92019C) is recalled due to issue related to the export of data from the… | Bio-Rad Laboratories | 08/20/2013Terminated |
| Z-0987-2013 Class II | ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative…Abbott has identified that assay files for the ARCHITECT HBsAg Qualitative and HBsAg Qualitative… | Abbott Laboratories, Inc | 12/18/2012Terminated |
| Z-1161-2013 Class III | VITROS Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen…Ortho Clinical Diagnostics is recalling certain lots of the Vitros Anti-HBs Reagent packs an inability to… | Ortho-Clinical Diagnostics | 11/01/2012Terminated |
| Z-2398-2012 Class II | The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog…Prolonged exposure of the MONOLISA Anti-HBs EIA Conjugate Diluent component to light may result in elevated… | Bio-Rad Laboratories | 07/27/2012Terminated |
| Z-1744-2011 | ETI-AB-AUK PLUS kits,REF P001931, DiaSorin S.p.A., 13040 Saluggia (VC), Italy…Through internal testing, DiaSorin has become aware that the kit lots identified (ETI-AB-AUK PLUS kits… | Diasorin Inc. | 08/19/2010Terminated |
| Z-1048-2009 | AxSYM CORE 2.0 Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM CORE 2.0…Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a… | Abbott Laboratories | 01/19/2009Terminated |
| Z-1046-2009 | AxSYM HBsAg Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM HBsAg is a…Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a… | Abbott Laboratories | 01/19/2009Terminated |
| Z-1620-2010 | Bio-Rad's Monolisa (TM) Anti-HBs EIA test kit, Labeled as, "MONOLISA TM Anti-HBs EIA…The package insert provided with this kit contains a typographical error, giving incorrect directions to… | Bio-Rad Laboratories | 08/11/2008Terminated |
| Z-0127-2008 | Abbott AxSYM AUSAB Reagent Pack, List No: 3C74-20, 100 tests, an in-vitro test for…Incorrect results: Reagents in these lots were manufactured with an incorrect ratio of 2 key components… | Abbott Laboratories | 10/01/2007Terminated |
| Z-0065-2008 | Bio-Rad Laboratories-MONOLISA Anti-HBc IGM EIA kit, an in-vitro diagnostic test kit…Incorrect Instruction: the package insert states to add 100L of conjugate; it should state to add 100uL. | Bio-Rad Laboratories | 09/05/2007Terminated |
| Z-1098-2007 | ARCHITECT AUSAB Controls list number 1L82-10 have two bottles with the following…During an internal study, the Architect AUSAB assay was found to read preparations of the WHO standard up to… | Abbott Diagnostic International, Ltd. | 05/14/2007Terminated |
| Z-1097-2007 | Architect AUSAB Calibrators IVD - list number 1L82-01 has six (6) bottles with the…During an internal study, the Architect AUSAB assay was found to read preparations of the WHO standard up to… | Abbott Diagnostic International, Ltd. | 05/14/2007Terminated |
| Z-1096-2007 | ARCHITECT AUSAB Reagent list number 1L82-25 has the following components: 1) Architect…During an internal study, the Architect AUSAB assay was found to read preparations of the WHO standard up to… | Abbott Diagnostic International, Ltd. | 05/14/2007Terminated |
| Z-1040-2007 | AxSYM HBsAg Reagent Pack; list 09B01; 100 test pack; in-vitro diagnostic; Abbott…Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can… | Abbott Laboratories | 04/23/2007Terminated |
| Z-1038-2007 | AxSYM CORE-M 2.0 Reagent Pack; list 08B89; 100 test pack; in-vitro diagnostic; Abbott…Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can… | Abbott Laboratories | 04/23/2007Terminated |
| Z-1037-2007 | AxSYM CORE 2.0 Reagent Pack; list 08B88; 100 test pack; in-vitro diagnostic; Abbott…Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can… | Abbott Laboratories | 04/23/2007Terminated |
| Z-1028-2007 | AxSYM AUSAB Reagent Pack; list 03C74; 100 test pack; in-vitro diagnostic; Abbott…Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can… | Abbott Laboratories | 04/23/2007Terminated |
| Z-0747-2007 | VITROS Immunodiagnostics Products HBsAg Reagent Pack, Catalog # 6801322: 1 Reagent Pack…Complaints of an increase in ''Reactive'' results with patient samples collected in sodium citrate or EDTA… | Ortho-Clinical Diagnostics | 02/01/2007Terminated |