Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
FDA Recall #Z-2322-2025 — Class II — July 10, 2025
Product Description
Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
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.
Recalling Firm
Beckman Coulter, Inc. — Chaska, MN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
453 units
Distribution
Worldwide - US Nationwide and the countries of Brazil, Canada, Georgia, Italy, Malaysia, Mexico, Philippines, Spain.
Code Information
UDI-DI: 15099590227173; Lot Number: 439163
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated