FDA Device recall Z-2322-2025
Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
- FDA Device
- Class II
- ongoing
- Published 2025-08-20
On 2025-08-20 the FDA classified a Class II recall of Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860 by Beckman Coulter, citing access Thyroglobulin reagent lot 439163 may generate erroneously high patient results. Falsely increased Access Thyroglobulin results may lead a physician to pursue unnecessary di….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2322-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-10 |
| Published | 2025-08-20 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
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.
Identifiers
| code_info | UDI-DI: 15099590227173; Lot Number: 439163 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2322-2025%22
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