Recall Z-2322-2025 ยท MSW System, Test, Thyroglobulin
Beckman Coulter, Inc.
Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
| Date | Aug 13, 2025 (initiated Jul 10, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | 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: |
| Quantity | 453 units |
| Distribution | Worldwide - US Nationwide and the countries of Brazil, Canada, Georgia, Italy, Malaysia, Mexico, Philippines, Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031269 | ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS Beckman Coulter, Inc., May 2, 2003 |