Z-0265-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 6, 2024
- Initiation Date
- September 5, 2024
- Termination Date
- N/A
- 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.