System, Test, Carcinoembryonic Antigen

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2018-05-04TerminatedError in labeling

  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.

• 2018-05-04TerminatedError in labeling

  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.

• 2015-11-06TerminatedUnder Investigation by firm

  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.

• 2011-03-11TerminatedPMA

  CEA ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.

  Product labels indicate that the products are for IVD use and they do not have an approved 510(k).

• 2006-08-01TerminatedOther

  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.

• 2005-07-16TerminatedOther

  Immulite/ Immulite 1000 Carcinoembryonic Antigen (CEA) LKCE1 lot 302 and 303

  Adverse trend in stability, controls biased or out of range.

• 2004-07-20TerminatedOther

  Immulite 1000 CEA Catalog No. LKCE1

  Instabililty

• 2004-01-06TerminatedOther

  Vitros Immunodiagnostic Products CEA REAGENT PACK, Lot 750, REF 192 0115, 100 coated wells per pack. Firm on the label: Ortho-Clinical Diagnostics, Amersham, UK.

  Reagent packs may contain wells that produce a low light signal that could result in calibration failures or negatively biased results.

• TerminatedDevice Design

  ST-AIA PACK CEA; Part Number: 025254 Assay, Tumor Marker

  Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.