Beckman Coulter, Inc. recalls Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The…

Recall date

September 5, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0265-2025

FDA classification

Class II

Brand / firm

Beckman Coulter, Inc.

Sold / distributed

Distribution was made nationwide to the U.S., including Puerto Rico. There was government distribution but no military distribution. Foreign distribution was made to Mexico.

Why it was recalled

IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access Thyroglobulin Antibody II (TgAb) assay is used for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems.