Beckman Coulter, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0265-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 5, 2024

Date Posted: November 6, 2024

Recall Number: Z-0265-2025

Event ID: 95407

Reason for Recall:

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

Status: Ongoing

Product Quantity: 465,481 kits

Code Information:

All IFU Part Numbers B14994, B63978, and A38168 affect all product/lots shipped from Jul-2021 to current; UDI-DI 15099590202910.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated