Beckman Coulter, Inc.: Medical Device Recall in 2025 - (Recall #: Z-2322-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860

Product Classification:

Class II

Date Initiated: July 10, 2025

Date Posted: August 20, 2025

Recall Number: Z-2322-2025

Event ID: 97255

Reason for Recall:

Access Thyroglobulin reagent lot 439163 may generate erroneously high patient results. Falsely increased Access Thyroglobulin results may lead a physician to pursue unnecessary diagnostic imaging studies and/or inappropriate therapy adjustments in patients being monitored for residual or recurrent thyroid cancer.

Status: Ongoing

Product Quantity: 453 units

Code Information:

UDI-DI: 15099590227173; Lot Number: 439163

Distribution Pattern:

Worldwide - US Nationwide and the countries of Brazil, Canada, Georgia, Italy, Malaysia, Mexico, Philippines, Spain.

Voluntary or Mandated:

Voluntary: Firm initiated