Z-0265-2025 Class II Ongoing
FDA device recall Z-0265-2025 was initiated by Beckman Coulter, Inc. on Sep 5, 2024 and is designated Class II. Reason for recall: IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results. The recall status is ongoing. Affected quantity: 465,481 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 6, 2024
- Initiation Date
- Sep 5, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 465,481 kits
Product Description
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 Pattern
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.
Code Information
All IFU Part Numbers B14994, B63978, and A38168 affect all product/lots shipped from Jul-2021 to current; UDI-DI 15099590202910.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0265-2025
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026