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Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
FDA product code LTK · Class 2 · Immunology
41
Registered devices
228
Adverse events
8
Recalls
26
510(k) clearances
Devices with this code
ARCHITECT — Abbott GmbHARCHITECT — Abbott GmbHADVIA Centaur® Systems CA 125II Calibrator — Siemens Healthcare Diagnostics Inc.Atellica IM CA 125II — Siemens Healthcare Diagnostics Inc.Access OV Monitor — Beckman Coulter, Inc.ARCHITECT — ABBOTT LABORATORIESARCHITECT — ABBOTT LABORATORIESIMMULITE® 2000 Systems OV OM-MA (CA125) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDCA-125 AccuLite CLIA Test System - 96 Wells — MONOBIND, INC.VITROS — ORTHO CLINICAL DIAGNOSTICSAIA-PACK CA 125 Sample Diluting Solution — TOSOH CORPORATIONAtellica IM CA 125II — Siemens Healthcare Diagnostics Inc.CA-125 AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.ARCHITECT — Abbott GmbHARCHITECT — ABBOTT LABORATORIESCA-125 AccuLite CLIA Test System - 192 Wells — MONOBIND, INC.ARCHITECT — ABBOTT LABORATORIESVITROS — ORTHO CLINICAL DIAGNOSTICSIMMULITE®/IMMULITE® 1000 Systems RTH Rapid TSH Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDVITROS — ORTHO CLINICAL DIAGNOSTICSADVIA Centaur® CA 125II — Siemens Healthcare Diagnostics Inc.Access OV Monitor Calibrators — Beckman Coulter, Inc.AIA-PACK CA 125 Calibrator Set — TOSOH CORPORATIONLumipulse G CA125II Immunoreaction Cartridges — FUJIREBIO 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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