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ImmunoWELL TPO IgG Quantitative Test

GenBio · Model 800-3020 · UDI-DI 00613745030203

510(k) clearances

Adverse events

Recalls

Facilities

Description

The ImmunoWELL TPO IgG Quantitative Test is a quantitative enzyme immunoassay (EIA) for screening and detection of autoantibodies against human thyroid peroxidase (microsome) in serum and is used as an aid in the diagnosis of thyroid disorders.

Recalls

Date	Firm	Reason
2024-09-05	Beckman Coulter, Inc.	IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results.
2019-04-30	Beckman 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: Free T3-REF A13422
2011-01-26	Beckman 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) reagent lot numbers id
2010-06-29	Beckman 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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.