Home › Device types › LOM
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA product code LOM · Class 2 · Microbiology
171
Registered devices
3,089
Adverse events
33
Recalls
1
510(k) clearances
Devices with this code
Alinity — Abbott Ireland DiagnosticsAlinity — Abbott GmbHGS — Bio-RAD Laboratories, Inc.Elecsys HBeAg immunoassay — Roche Diagnostics GmbHIMMULITE® Systems HBsAg Confirmatory Kit — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDGS — Bio-RAD Laboratories, Inc.MONOLISA™ — Bio-RAD Laboratories, Inc.ARCHITECT — Abbott GmbHARCHITECT — Abbott Ireland DiagnosticsElecsys PreciControl Anti-HBc IgM — Roche Diagnostics GmbHElecsys Anti-HBe — Roche Diagnostics GmbHARCHITECT — Abbott Ireland DiagnosticsAlinity — Abbott Ireland DiagnosticsIMMULITE®/IMMULITE®1000 Systems aHB Anti-HBs — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDVITROS — ORTHO CLINICAL DIAGNOSTICSVITROS — ORTHO CLINICAL DIAGNOSTICSElecsys Anti-HBc IgM — Roche Diagnostics GmbHARCHITECT — Abbott Ireland DiagnosticsElecsys HBsAg Confirmatory Test — Roche Diagnostics GmbHAlinity — Abbott GmbHARCHITECT — Abbott Ireland DiagnosticsARCHITECT — Abbott Ireland DiagnosticsAlinity — Abbott GmbHADVIA Centaur® HBsAg — Siemens Healthcare Diagnostics Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-24 | Mckesson Medical-Surgical Inc. Corporate Office | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage con |
| 2025-04-24 | Mckesson Medical-Surgical Inc. Corporate Office | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage con |
| 2024-03-01 | Ortho-Clinical Diagnostics, Inc. | Potential for positively biased results due to signal reduction over shelf life. |
| 2023-11-27 | Ortho-Clinical Diagnostics, Inc. | Affected lots may experience increased calibration failures or an increase in falsely elevated results. |
| 2022-12-22 | Siemens Healthcare Diagnostics, Inc. | Anti-HBe2 (aHBe2) interference with the Hepatitis B e Antigen (HBeAg) Assay, leads to elevated or reactive Hepatitis B e Antigen (HBeAg) results on samples that |
| 2018-11-01 | ORTHO-CLINICAL DIAGNOSTICS | The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin conc |
| 2018-11-01 | ORTHO-CLINICAL DIAGNOSTICS | The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin conc |
| 2018-01-02 | Siemens Healthcare Diagnostics, Inc. | Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista |
| 2018-01-02 | Siemens Healthcare Diagnostics, Inc. | Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista |
| 2014-09-15 | Siemens Healthcare Diagnostics, Inc | Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results. |
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