Acid, Folic, Radioimmunoassay
Clinical Chemistry · 21 CFR 862.1295
Recent MDR events
150 adverse event reports on file
- ELECSYS FOLATE IIIJul 21, 2026MalfunctionRoche Diagnostics1823260-2026-02955
- ELECSYS FOLATE IIIMar 11, 2026MalfunctionRoche Diagnostics1823260-2026-00868
- ELECSYS FOLATE IIIFeb 19, 2026MalfunctionRoche Diagnostics1823260-2026-00591
- ELECSYS FOLATE IIIFeb 11, 2026MalfunctionRoche Diagnostics1823260-2026-00474
- ELECSYS FOLATE IIIJan 2, 2026MalfunctionRoche Diagnostics1823260-2026-00013
- ELECSYS FOLATE IIIDec 30, 2025MalfunctionRoche Diagnostics1823260-2025-05368
- ELECSYS FOLATE IIIOct 27, 2025MalfunctionRoche Diagnostics1823260-2025-04360
- ELECSYS FOLATE IIIOct 9, 2025MalfunctionRoche Diagnostics1823260-2025-04133
- ELECSYS FOLATE IIIOct 1, 2025MalfunctionRoche Diagnostics1823260-2025-04016
- ELECSYS FOLATE IIIAug 19, 2025MalfunctionRoche Diagnostics1823260-2025-02546
Event type breakdown
Recalls
28 recall events for this product code
- Ortho-Clinical Diagnostics, Inc.Open, ClassifiedAug 12, 2024
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
It was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon the addition of folate stabilizer reagent as part of the pre-treatment process causing the increase in "TM5-4MB" condition codes which lead to a delay of results.
Z-2580-2024 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.Open, ClassifiedFeb 21, 2023
Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells.
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
Z-1149-2023 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.Open, ClassifiedFeb 21, 2023
Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells.
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
Z-1150-2023 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.Open, ClassifiedFeb 21, 2023
Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination of folate in human serum and red blood cells.
Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples.
Z-1151-2023 · View FDA record ↗ - Siemens Healthcare Diagnostics, IncTerminatedJan 21, 2020
Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells
Homocysteine Assay May Cause Elevated Results in the Folate Assay
Z-0829-2020 · View FDA record ↗ - Siemens Healthcare Diagnostics, IncTerminatedJan 21, 2020
Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells
Homocysteine Assay May Cause Elevated Results in the Folate Assay
Z-0830-2020 · View FDA record ↗ - Siemens Healthcare Diagnostics, IncTerminatedJan 21, 2020
Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red blood cell
Homocysteine Assay May Cause Elevated Results in the Folate Assay
Z-0831-2020 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.TerminatedMay 4, 2018
IMMULITE 2000/IMMULITE 2000 XPi Folic Acid
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-1676-2018 · View FDA record ↗ - Siemens Healthcare Diagnostics, Inc.TerminatedMay 4, 2018
ADVIA Centaur Folate (FOL)
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-1689-2018 · View FDA record ↗ - Siemens Healthcare Diagnostics, IncTerminatedSep 4, 2015
ADVIA Centaur Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877.
Low red blood cell control recoveries and low results for red blood cell patient samples when using the ADVIA Centaur Systems Folate assay.
Z-2739-2015 · View FDA record ↗
Registered firms
59 firms currently registered for this product code
Tosoh Bioscience, Inc.
Grove City, OH, US
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Tosoh Aia, Inc.
TOYAMA, JP
Monobind, Inc.
Lake Forest, CA, US
Beckman Coulter Biomedical Gmbh
Munchen Bavaria, DE
Siemens Healthcare Diagnostics Inc.
NEWARK, DE, US
Diasorin Inc.
Stillwater, MN, US
Diamond Diagnostics Inc.
Budapest, HU
Tosoh Corp.
Chuo-ku Tokyo, JP
Beckman Coulter Ireland Inc
O CALLAGHANS MILLS Clare, IE
Ortho-clinical Diagnostics, Inc.
RARITAN, NJ, US
Siemens Healthcare Diagnostics Products Limited
LLANBERIS Wales, GB
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Diafarma Ecza Deposu Ve Medikal Dis Ticaret Dis Tic Ltd Sti
Istanbul, TR
Abbott Ireland Diagnostics Division
Longford, IE
Sensor Health Products, Inc.
CAMBRIDGE Ontario, CA
Siemens Healthcare Diagnostics Manufacturing Ltd.
SWORDS Dublin, IE
Roche Diagnostics Gmbh
PENZBERG Bavaria, DE
510(k) clearances
64 clearances for this product code
- Roche DiagnosticsJun 17, 2024
K233060 · Elecsys Folate III
- Beckman Coulter, Inc.Aug 23, 2023
K223590 · Access Folate Assay
- DiaSorin, Inc.May 6, 2020
K192586 · LIAISON® Folate
- Siemens Healthcare Diagnostics, Inc.Apr 12, 2018
K172201 · Atellica IM Folate Assay
- Diazyme LaboratoriesNov 4, 2016
K161646 · Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set
- Roche DiagnosticsOct 17, 2014
K141426 · ELECSYS FOLATE III
- Roche DiagnosticsMay 12, 2011
K103716 · ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET
- Abbott LaboratoriesMar 5, 2010
K092740 · ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74