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Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
FDA product code LTK · Class 2 · Immunology
41
Registered devices
230
Adverse events
8
Recalls
26
510(k) clearances
Devices with this code
CA-125 AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.Elecsys CA 125 II — Roche Diagnostics GmbHARCHITECT — ABBOTT LABORATORIESVITROS — ORTHO CLINICAL DIAGNOSTICSAtellica IM CA 125II — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® CA 125 II — Siemens Healthcare Diagnostics Inc.ADVIA Centaur® Systems CA 125II Calibrator — Siemens Healthcare Diagnostics Inc.Alinity — Abbott GmbHARCHITECT — ABBOTT LABORATORIESVITROS — ORTHO CLINICAL DIAGNOSTICSARCHITECT — ABBOTT LABORATORIESADVIA Centaur® CA 125II — Siemens Healthcare Diagnostics Inc.IMMULITE®/IMMULITE® 1000 Systems RTH Rapid TSH Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDIMMULITE® 2000 Systems OM-MA Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDAlinity — Abbott GmbHLumipulse G CA125II Immunoreaction Cartridges — FUJIREBIO INC.ARCHITECT — ABBOTT LABORATORIESAIA-PACK CA 125 Sample Diluting Solution — TOSOH CORPORATIONAtellica IM CA 125II — Siemens Healthcare Diagnostics Inc.ARCHITECT — Abbott GmbHADVIA Centaur® CA 125II MCM — Siemens Healthcare Diagnostics Inc.IMMULITE®/IMMULITE® 1000 Systems OMM OM-MA Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDARCHITECT — Abbott GmbHAtellica IM CA 125II Calibrator — Siemens Healthcare Diagnostics Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-02-21 | Siemens Healthcare Diagnostics, Inc | Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use. |
| 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 |
| 2013-10-09 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products CA 125 II Reagent Pack and Calibrators due to a positiv |
| 2010-12-22 | BioCheck Inc | Product labels indicate that the products are for IVD use and they do not have an approved 510(k). |
| 2010-12-22 | BioCheck Inc | Product labels indicate that the products are for IVD use and they do not have an approved 510(k). |
| 2010-12-14 | Siemens Healthcare Diagnostics, Inc | Positive bias (40-55%) with patient results greater than the upper limit of normal and less than the upper limit of normal |
| 2007-04-23 | Abbott Laboratories | Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placem |
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