Z-2322-2025Class II

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

Name: Z-2322-2025 Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
Creator: Beckman Coulter, Inc.
Published: 2025-07-10
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2025-07-10 / Open, Classified

FDA source

Beckman Coulter, Inc. began a recall of Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860 on 2025-07-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2322-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-10
Posted: 2025-08-13
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
Product code: MSW System, Test, Thyroglobulin
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.
FDA 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 in commerce: 453 units
Distribution: Worldwide - US Nationwide and the countries of Brazil, Canada, Georgia, Italy, Malaysia, Mexico, Philippines, Spain.
Product codes and lots: UDI-DI: 15099590227173; Lot Number: 439163

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2322-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2322-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-20	2025-08-13

Product code MSW

K031269Class IIAccess Thyroglobulin Reagents on the Access Immunoassay SystemsBeckman Coulter, Inc. / cleared 2003-05-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)