Immunochemical, Thyroglobulin Autoantibody
Immunology · 21 CFR 866.5870
Recent MDR events
15 adverse event reports on file
- ACCESS THYROGLOBULINAug 12, 2025InjuryBeckman Coulter, Inc.2122870-2025-00090
- IMMULITE® 2000 THYROGLOBULINDec 8, 2022MalfunctionSiemens Healthcare Diagnostics Products, Limited2432235-2022-00377
- IMMULITE® 2000 THYROGLOBULINDec 8, 2022MalfunctionSiemens Healthcare Diagnostics Products, Limited2432235-2022-00375
- IMMULITE® 2000 THYROGLOBULINDec 8, 2022MalfunctionSiemens Healthcare Diagnostics Products, Limited2432235-2022-00376
- IMMULITE® 2000 THYROGLOBULINDec 8, 2022MalfunctionSiemens Healthcare Diagnostics Products, Limited2432235-2022-00373
- IMMULITE® 2000 THYROGLOBULINDec 8, 2022MalfunctionSiemens Healthcare Diagnostics Products, Limited2432235-2022-00380
- IMMULITE® 2000 THYROGLOBULINDec 8, 2022MalfunctionSiemens Healthcare Diagnostics Products, Limited2432235-2022-00374
- IMMULITE® 2000 THYROGLOBULINDec 8, 2022MalfunctionSiemens Healthcare Diagnostics Products, Limited2432235-2022-00372
- IMMULITE® 2000 THYROGLOBULINMay 27, 2022MalfunctionSiemens Healthcare Diagnostics Products, Limited2247117-2022-00019
- ACCESS THYROGLOBULINJun 7, 2021InjuryBeckman Coulter2122870-2021-00078
Event type breakdown
Recalls
4 recall events for this product code
- Beckman Coulter, Inc.Open, ClassifiedOct 30, 2024
Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168.
IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results.
Z-0265-2025 · View FDA record ↗ - Beckman Coulter Inc.TerminatedJun 2, 2020
Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin Antibody II, REF A32898 (UDI: 15099590202910) for use with the Access Family of Immunoassay S
The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total T3-REF 33830, Free T4-REF 33880, GI Mon-387687, Tg-REF 33860, and TgAbII-REF A32898 displayed significant interference (defined as a result bias greater than +/-10%) at 1,200 ng/mL of biotin.
Z-2242-2020 · View FDA record ↗ - Beckman Coulter Inc.TerminatedMar 24, 2011
Access Thyroglobulin Antibody II, Part Number: A32898
The recall was initiated after Beckman Coulter confirmed customer reports of reagent pack to pack variability for the Access Thyroglobulin Antibody II (TgAb) reagent lot numbers identified in the recall. Erroneous results for patient and quality control samples can be generated. The Thyroglobulin Antibody II (TgAbII) reagent lots may produce: (1) Erroneously high TgAb results for both quality co
Z-1818-2011 · View FDA record ↗ - Beckman Coulter Inc.TerminatedSep 2, 2010
Beckman Coulter Access Thyroglobulin Antibody II Reagent, Part Number: A32898. The Access Thyroglobulin Antibody II (TgAb) assay intended use is for the quanti
The affected Access Thyroglobulin Antibody II reagent may produce inaccurate results due to a change in the thyroglobulin that was used in the kits.
Z-2355-2010 · View FDA record ↗
Registered firms
13 firms currently registered for this product code
Trinity Biotech Usa
Jamestown, NY, US
Immunocentrix Corporation
Canoga Park, CA, US
Siemens Healthcare Diagnostics Inc.
Tarrytown, NY, US
Siemens Healthcare Diagnostics Inc.
E Walpole, MA, US
Monobind, Inc.
Lake Forest, CA, US
Drg International, Inc.
Springfield, NJ, US
Beckman Coulter, Inc.
CHASKA, MN, US
Epitope Diagnostics, Inc.
SAN DIEGO, CA, US
Diagnostic Automation/ Cortez Diagnostics Inc,.
Woodland Hills, CA, US
Siemens Healthcare Diagnostics Products Limited
LLANBERIS Wales, GB
Sensor Health Products, Inc.
CAMBRIDGE Ontario, CA
Drg Instruments Gmbh
MARBURG Hesse, DE
510(k) clearances
22 clearances for this product code
- Siemens Healthcare Diagnostics, Inc.Dec 4, 2025
K250816 · ADVIA Centaur Anti-Thyroglobulin II (aTgII)
- Beckman Coulter, Inc.Jul 3, 2024
K240996 · Access Thyroglobulin Antibody II
- Beckman Coulter, Inc.Dec 27, 2011
K112933 · ACCESS THYROGLOBULIN ANITBODY
- Phadia US, Inc.Nov 20, 2007
K072661 · IMMUNOCAP THYRLOBULIN IMMUNOCAP
- Beckman Coulter, Inc.Oct 5, 2006
K062516 · ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)
- MonobindJul 3, 1997
K971834 · ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA
- Hycor Biomedical, Inc.Nov 25, 1996
K962451 · HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO)
- Hycor Biomedical, Inc.Nov 25, 1996
K962341 · HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG)