# FDA recall Z-0265-2025

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2024-09-05.

## Product

Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168.  The Access Thyroglobulin Antibody II (TgAb) assay is used for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems.

## Reason for recall

IFUs for the device incorrectly states the biotin interference was remediated.  The issue could result in potentially false-low results.

## Distribution

Distribution was made nationwide to the U.S., including Puerto Rico.   There was government distribution but no military distribution.  Foreign distribution was made to Mexico.

## Key facts

- **Recall number:** Z-0265-2025
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-05
- **Report date:** 2024-11-06

- **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-0265-2025

## Citation

> AI Analytics. FDA recall Z-0265-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0265-2025. Source: US FDA. Licensed CC0.

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