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

Recalled November 6, 2024 · FDA recall Z-0265-2025 · Beckman Coulter

Hazard

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

Units

465,481 kits

Sold at

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.

Description

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

Product

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.

Manufacturer(s)

Beckman Coulter, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →