—#214974

Product

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

FDA product code: MSW — System, Test, Thyroglobulin
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K031269
Affected lot / code info: UDI-DI: 15099590227173; Lot Number: 439163

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter, Inc.
Address: 1000 Lake Hazeltine Dr, Chaska, Minnesota 55318-1037

Distribution

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

Timeline

Recall initiated: 2025-07-10
Posted by FDA: 2025-08-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #214974. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.