# FDA recall Z-2322-2025

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2025-07-10.

## 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.

## Distribution

Worldwide - US Nationwide and the countries of Brazil, Canada, Georgia, Italy, Malaysia, Mexico, Philippines, Spain.

## Key facts

- **Recall number:** Z-2322-2025
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-10
- **Report date:** 2025-08-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chaska, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2322-2025

## Citation

> AI Analytics. FDA recall Z-2322-2025. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-2322-2025. Source: US FDA. Licensed CC0.

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