Access Thyroglobulin Antibody II — Class II medical device recall Z-0265-2025
Ongoing recall by Beckman Coulter, Inc., reported 2024-11-06, distributed nationwide. IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in poten
| Recall number | Z-0265-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2024-09-05 |
| Classified | 2024-10-30 |
| Reported by FDA | 2024-11-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX |
| Quantity | 465,481 kits |
| UPC / GTIN / UDI-DI | 15099590202910 |
| Model numbers | A32898, A38168, B14994, B63978 |
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.
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-0265-2025. 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.