Recall Z-2322-2025— Beckman Coulter, Inc.

Name: FDA recall Z-2322-2025
Creator: U.S. Food and Drug Administration
Published: 2025-07-10

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter, Inc., initiated 2025-07-10. It names one FDA 510(k) clearance: K031269. Product: Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860. Reason: 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.
Classification: Class II
Status: Ongoing
Initiated: 2025-07-10
Firm location: Chaska, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K031269 — ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMSBeckman Coulter, Inc.·cleared 2003-05-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.