Access Thyroglobulin assay — Class II medical device recall Z-2322-2025
Ongoing recall by Beckman Coulter, Inc., reported 2025-08-20, distributed nationwide. Access Thyroglobulin reagent lot 439163 may generate erroneously high patient results. Falsely increased Acces
| Recall number | Z-2322-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2025-07-10 |
| Classified | 2025-08-13 |
| Reported by FDA | 2025-08-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CA, ES, IT, MX, MY, PH |
| Quantity | 453 units |
| UPC / GTIN / UDI-DI | 15099590227173 |
| Lot numbers | 439163 |
| Model numbers | 33860 |
Product
Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2322-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.