Home › Device types › DHX
System, Test, Carcinoembryonic Antigen
FDA product code DHX · Class 2 · Immunology
46
Registered devices
310
Adverse events
9
Recalls
28
510(k) clearances
Devices with this code
Monobind AccuLite CEA Next Generation CLIA Kit - 192 Wells — MONOBIND, INC.Access CEA Calibrators — Beckman Coulter, Inc.ADVIA Centaur® CEA Diluent — Siemens Healthcare Diagnostics Inc.Access CEA Diluent — Beckman Coulter, Inc.Atellica IM CEA DIL — Siemens Healthcare Diagnostics Inc.CEA AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.Alinity — Abbott Ireland DiagnosticsAlinity — Abbott Ireland DiagnosticsAlinity — Abbott Ireland DiagnosticsCEA-NG AccuLite CLIA Test System - 96 Wells — MONOBIND, INC.VITROS — ORTHO CLINICAL DIAGNOSTICSVITROS — ORTHO CLINICAL DIAGNOSTICSADVIA Centaur® CEA — Siemens Healthcare Diagnostics Inc.Elecsys CEA — Roche Diagnostics GmbHARCHITECT — Abbott Ireland DiagnosticsCEA-NG AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.Atellica IM CEA — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® CEA — Siemens Healthcare Diagnostics Inc.CEA AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.IMMULITE® 2000 Systems CEA — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDARCHITECT — Abbott Ireland DiagnosticsAlinity — Abbott Ireland DiagnosticsElecsys CEA Assay — Roche Diagnostics GmbHAIA-PACK CEA Sample Diluting Solution — TOSOH CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-03-05 | Tosoh Bioscience Inc | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, dependin |
| 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 |
| 2015-10-13 | Beckman Coulter Inc. | Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly. |
| 2010-12-22 | BioCheck Inc | Product labels indicate that the products are for IVD use and they do not have an approved 510(k). |
| 2006-04-12 | Beckman Coulter Inc | Firm has confirmed that the Access CEA Assay may generate decreased values with certain frozen platelet specimens. |
| 2005-05-26 | Diagnostic Products Corp | Adverse trend in stability, controls biased or out of range. |
| 2004-05-03 | Diagnostic Products Corp | Instabililty |
| 2003-12-03 | Ortho-Clinical Diagnostics | Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.