Test, Epithelial Ovarian Tumor-associated Antigen (ca125)
Immunology · 21 CFR 866.6010
Recent MDR events
228 adverse event reports on file
- Elecsys CA 125 IIJul 29, 2026MalfunctionRoche Diagnostics1823260-2026-03062
- ALINITY I CA 125 II REAGENT KITMar 31, 2026MalfunctionAbbott Gmbh3002809144-2026-00079
- IMMULITE 2000 OM-MAMar 24, 2026MalfunctionSiemens Healthcare Diagnostics Products, Limited1219913-2026-00061
- ALINITY I CA 125 II REAGENT KITMar 20, 2026MalfunctionAbbott Gmbh3002809144-2026-00069
- ATELLICA IM CA 125IIMar 18, 2026MalfunctionSiemens Healthcare Diagnostics Inc.1219913-2026-00058
- ELECSYS CA 125 IINov 21, 2025MalfunctionRoche Diagnostics1823260-2025-04791
- ATELLICA IM CA 125II¿ (CA 125II¿)Jun 20, 2025MalfunctionSiemens Healthcare Diagnostics, Inc.1219913-2025-00121
- ELECSYS CA 125 IIMay 30, 2025MalfunctionRoche Diagnostics1823260-2025-01673
- IMMULITE 2000 OM-MAFeb 14, 2025MalfunctionSiemens Healthcare Diagnostics Products, Limited1219913-2025-00039
- ELECSYS CA 125 IIDec 20, 2024MalfunctionRoche Diagnostics1823260-2024-03771
Event type breakdown
Recalls
8 recall events for this product code
- Siemens Healthcare Diagnostics, Inc.TerminatedMay 4, 2018
IMMULITE /IMMULITE 1000 OM-MA (CA125)
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 MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.
Z-1682-2018 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.TerminatedMay 4, 2018
IMMULITE 2000/IMMULITE 2000 XPi OM-MA (CA125)
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 MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.
Z-1683-2018 · View FDA record ↗ - Ortho-Clinical DiagnosticsTerminatedDec 17, 2013
VITROS CA 125 II Calibrators
Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products CA 125 II Reagent Pack and Calibrators due to a positive shift in patient results.
Z-0525-2014 · View FDA record ↗ - BioCheck IncTerminatedMar 11, 2011
CA125 ELISA Kit.
Product labels indicate that the products are for IVD use and they do not have an approved 510(k).
Z-1628-2011 · View FDA record ↗ - BioCheck IncTerminatedMar 11, 2011
CA15-3 ELISA Kit.
Product labels indicate that the products are for IVD use and they do not have an approved 510(k).
Z-1629-2011 · View FDA record ↗ - Siemens Healthcare Diagnostics, IncTerminatedMar 2, 2011
ADVIA Centaur CA 125 II Assay packaged in 100 and 500 test kits as follows:
Positive bias (40-55%) with patient results greater than the upper limit of normal and less than the upper limit of normal
Z-1477-2011 · View FDA record ↗ - Abbott LaboratoriesTerminatedJul 11, 2007
AxSYM CA 125 Reagent Pack; list 03B41; 100 test pack; an in vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064
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 placement of the reagent kit on the AxYM instrument.
Z-1026-2007 · View FDA record ↗ - Siemens Healthcare Diagnostics, IncTerminatedUnknown
ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, SMN 10315696 (5-pack/500 tests)
Upon dilution, some patient samples may exhibit over-recovery outside the representative data provided in the assay instructions for use.
Z-1486-2018 · View FDA record ↗
Registered firms
44 firms currently registered for this product code
Fujirebio Inc.
Sagamihara-shi Kanagawa, JP
Otsuka Electronics Co., Ltd.
Koka-city Shiga, JP
Tosoh Bioscience, Inc.
Grove City, OH, US
Fujirebio Diagnostics, Inc.
Malvern, PA, US
Sensor Health Products, Inc.
CAMBRIDGE Ontario, CA
Diamond Diagnostics Inc.
Budapest, HU
Tosoh Aia, Inc.
TOYAMA, JP
Acro Biotech Inc.
Montclair, CA, US
Fujirebio Inc. Ube Facility
Yamaguchi, JP
Tosoh Corp.
Chuo-ku Tokyo, JP
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Siemens Healthcare Diagnostics Products Limited
LLANBERIS Wales, GB
Diafarma Ecza Deposu Ve Medikal Dis Ticaret Dis Tic Ltd Sti
Istanbul, TR
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Ortho-clinical Diagnostics, Inc.
RARITAN, NJ, US
Ortho Clinical Diagnostics, K.k.
Harumi, Chuo-ku Tokyo, JP
Ortho Clinical Diagnostics
Singapore South West, SG
510(k) clearances
26 clearances for this product code
- Beckman Coulter, Inc.May 10, 2024
K240479 · Access OV Monitor
- Siemens Healthcare Diagnostics Products, Ltd.Sep 8, 2023
K213510 · IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA
- Ortho Clinical DiagnosticsDec 12, 2022
K221355 · VITROS Immuodiagnostic Products CA 125 II Reagent Pack
- Siemens Healthcare Diagnostics, Inc.Apr 6, 2020
K200199 · ADVIA Centaur CA 125II
- Roche Professional DiagnosticsAug 6, 2015
K143534 · Elecsys CA-125 II assay
- Fujirebio Diagnostics,Inc.May 21, 2015
K142895 · LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators
- Siemens Healthcare DiagnosticsApr 12, 2011
K100321 · DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604
- bioMerieux, Inc.Jun 22, 2009
K080469 · VIDAS CA 15-3 ASSAY