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.

Code information: All IFU Part Numbers B14994, B63978, and A38168 affect all product/lots shipped from Jul-2021 to current; UDI-DI 15099590202910.

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.