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Immunochemical, Thyroglobulin Autoantibody

FDA product code JNL · Class 2 · Immunology

13
Registered devices
15
Adverse events
4
Recalls
22
510(k) clearances

Devices with this code

Anti-Thyroid Peroxidase (Anti-TPO) ELISA — DRG International IncImmunoWELL TPO IgG Quantitative Test — GenBioAutostat II Anti-Thyroid Peroxidase — HYCOR BIOMEDICAL LLCImmunoDOT Thyroid Positive Control — GenBioTrinity Biotech — CLARK LABORATORIES, INC.ImmunoDOT Thyroid Autoimmunity Panel — GenBioAnti-TPO AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.Monobind AccuLite Anti-TPO CLIA Kit - 96 Wells — MONOBIND, INC.ImmunoCAP Specific IgG, Antigen tg, Thyroglobulin — Phadia ABImmunoDOT Thyroid Autoimmunity Panel — GenBioImmunoWELL Thyroglobulin IgG Quantitative Test — GenBioAccess Thyroglobulin Antibody II — Beckman Coulter, Inc.Anti-Thyroid Peroxidase (Anti-TPO) ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung

Recent recalls

DateFirmReason
2024-09-05Beckman Coulter, Inc.IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results.
2019-04-30Beckman Coulter Inc.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
2011-01-26Beckman Coulter Inc.The recall was initiated after Beckman Coulter confirmed customer reports of reagent pack to pack variability for the Access Thyroglobulin Antibody II (TgAb) re
2010-06-29Beckman Coulter Inc.The affected Access Thyroglobulin Antibody II reagent may produce inaccurate results due to a change in the thyroglobulin that was used in the kits.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.