System, Test, Carcinoembryonic Antigen
Immunology · 21 CFR 866.6010
Recent MDR events
308 adverse event reports on file
- Elecsys CEAJul 28, 2026MalfunctionRoche Diagnostics1823260-2026-03007
- ELECSYS CEAJul 2, 2026MalfunctionRoche Diagnostics1823260-2026-02677
- ALINITY I CEA REAGENT KITJun 4, 2026MalfunctionAbbott Ireland Diagnostics Division3008344661-2026-00085
- ELECSYS CEAMay 22, 2026MalfunctionRoche Diagnostics1823260-2026-02024
- ALINITY I CEA REAGENT KITMay 18, 2026MalfunctionAbbott Ireland Diagnostics Division3008344661-2026-00073
- ATELLICA IMApr 10, 2026MalfunctionSiemens Healthcare Diagnostics Inc.1219913-2026-00075
- ATELLICA IM CARCINOEMBRYONIC ANTIGEN (CEA)Jan 23, 2026MalfunctionSiemens Healthcare Diagnostics, Inc.1219913-2026-00023
- ELECSYS CEAJan 20, 2026MalfunctionRoche Diagnostics1823260-2026-00203
- ELECSYS CEAJan 15, 2026MalfunctionRoche Diagnostics1823260-2026-00184
- ELECSYS CEAJan 12, 2026MalfunctionRoche Diagnostics1823260-2026-00132
Event type breakdown
Recalls
9 recall events for this product code
- Siemens Healthcare Diagnostics, Inc.TerminatedMay 4, 2018
IMMULITE /IMMULITE 1000 CEA
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-1678-2018 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.TerminatedMay 4, 2018
IMMULITE 2000/IMMULITE 2000 XPi CEA
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-1679-2018 · View FDA record ↗ - Beckman Coulter Inc.TerminatedNov 6, 2015
Access CEA Assay, Part No. 33200. For the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum.
Beckman Coulter is recalling the Access CEA reagent packs because they were filled incorrectly.
Z-0239-2016 · View FDA record ↗ - BioCheck IncTerminatedMar 11, 2011
CEA ELISA Kit.
Product labels indicate that the products are for IVD use and they do not have an approved 510(k).
Z-1627-2011 · View FDA record ↗ - Beckman Coulter IncTerminatedAug 1, 2006
Access Immunoassay system CEA, in vitro diagnostic, Part No. 33200
Firm has confirmed that the Access CEA Assay may generate decreased values with certain frozen platelet specimens.
Z-1313-06 · View FDA record ↗ - Diagnostic Products CorpTerminatedJul 16, 2005
Immulite/ Immulite 1000 Carcinoembryonic Antigen (CEA) LKCE1 lot 302 and 303
Adverse trend in stability, controls biased or out of range.
Z-1015-05 · View FDA record ↗ - Diagnostic Products CorpTerminatedJul 20, 2004
Immulite 1000 CEA
Instabililty
Z-0972-04 · View FDA record ↗ - Ortho-Clinical DiagnosticsTerminatedJan 6, 2004
Vitros Immunodiagnostic Products CEA REAGENT PACK, Lot 750, REF 192 0115, 100 coated wells per pack. Firm on the label: Ortho-Clinical Diagnostics, Amersham,
Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results.
Z-0299-04 · View FDA record ↗ - Tosoh Bioscience IncTerminatedUnknown
ST-AIA PACK CEA; Part Number: 025254
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Z-2066-2018 · View FDA record ↗
Registered firms
45 firms currently registered for this product code
Ortho Clinical Diagnostics
Singapore South West, SG
Tosoh Bioscience, Inc.
Grove City, OH, US
Tosoh Aia, Inc.
TOYAMA, JP
Diamond Diagnostics Inc.
Budapest, HU
Monobind, Inc.
Lake Forest, CA, US
Ortho-clinical Diagnostics European Support Center
Illkirch, CEDEX Bas-Rhin, FR
Siemens Healthcare Diagnostics Inc.
NEWARK, DE, US
Epitope Diagnostics, Inc.
SAN DIEGO, CA, US
Acro Biotech Inc.
Montclair, CA, US
Siemens Healthcare Diagnostics Inc.
E Walpole, MA, US
Tosoh Corp.
Chuo-ku Tokyo, JP
Siemens Healthcare Diagnostics Products Limited
LLANBERIS Wales, GB
Beckman Coulter, Inc.
CHASKA, MN, US
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Diafarma Ecza Deposu Ve Medikal Dis Ticaret Dis Tic Ltd Sti
Istanbul, TR
Ortho-clinical Diagnostics, Inc.
RARITAN, NJ, US
Abbott Laboratories
Lake Forest, IL, US
Ortho-clinical Diagnostics
Pencoed Bridgend, GB
Abbott Ireland
SLIGO, IE
510(k) clearances
28 clearances for this product code
- Beckman Coulter, Inc.Sep 22, 2023
K223921 · Access CEA
- Ortho Clinical DiagnosticsAug 23, 2023
K231517 · VITROS Immunodiagnostic Products CEA Reagent Pack
- Siemens Healthcare Disgnostics, Inc.Apr 13, 2020
K200215 · ADVIA Centaur CEA Assay
- Olympus America, Inc.Mar 18, 2009
K081615 · OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN
- bioMerieux, Inc.Oct 9, 2008
K080194 · VIDAS CEA (S) ASSAY
- Dade Behring, Inc.Jun 25, 2008
K071603 · DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)
- Ortho-Clinical Diagnostics, Inc.Jun 17, 2004
K041322 · VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS
- Beckman Coulter, Inc.May 6, 2003
K031270 · ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS