FDA Medical Device Recalls (openFDA)
Beckman Coulter, Inc.: Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
- Recall number
- Z-2322-2025
- Recalling firm
- Beckman Coulter, Inc.
- Product
- Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
- Status
- Open, Classified
- Initiated
- 2025-07-10
- Posted
- 2025-08-13
- Terminated
- not on file
- 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: 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.
- Quantity
- 453 units
- Distribution
- Worldwide - US Nationwide and the countries of Brazil, Canada, Georgia, Italy, Malaysia, Mexico, Philippines, Spain.
- Lot, serial or model codes
- UDI-DI: 15099590227173; Lot Number: 439163
- 510(k) numbers
- K031269
- PMA numbers
- not on file
- Product code
- MSW
- Firm FEI
- 2122870
- Firm city
- Chaska
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28