Medical Device Recall: 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 deter
Beckman Coulter, Inc. · September 5, 2024
Reason for Recall
IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results.
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.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
465,481 kits
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0265-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.