FDA Device recall Z-0265-2025
Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168
- FDA Device
- Class II
- ongoing
- Published 2024-11-06
On 2024-11-06 the FDA classified a Class II recall of Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168 by Beckman Coulter, citing IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0265-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-05 |
| Published | 2024-11-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Beckman Coulter |
| Distribution | US |
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
IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results.
Identifiers
| code_info | All IFU Part Numbers B14994, B63978, and A38168 affect all product/lots shipped from Jul-2021 to current; UDI-DI 15099590202910. |
|---|
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-0265-2025%22
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