Beckman Coulter, Inc. recalls Access Thyroglobulin assay

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.

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

An URGENT MEDICAL DEVICE RECALL notification dated 7/2/25 was sent to customers. ACTION: " Discontinue using Access Thyroglobulin reagent lot 439163 and discard all remaining reagent packs from this lot. " At the discretion of the medical director, a retrospective review of patient results generated with Access Thyroglobulin reagent lot 439163 should be performed, which includes reviewing patient history, to assess the need for retesting. " Please contact your local Beckman Coulter representative for replacement product requests and to receive updates on availability and delivery. RESOLUTION: Beckman Coulter is investigating the root cause of this issue to prevent similar occurrences. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: " Electronically, if you received this communication via email. " Manually, complete and return the enclosed Response Form. If you have any questions regarding this notice, please contact our Customer Support Center: " From our website: http://www.beckmancoulter.com " Contact your local Beckman Coulter Representative for replacement.

• FDA enforcement recordOfficial FDA database entry for Z-2322-2025
• FDA 510(k) clearance · K031269The device's official FDA premarket clearance record
• FDA device classification · MSWOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.6010The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Beckman Coulter, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.