Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Access Thyroglobulin Antibody II Recalled by Beckman Coulter, Inc. Due to IFUs for the device incorrectly states the biotin...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Beckman Coulter, Inc. directly.
Affected Products
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.
Quantity: 465,481 kits
Why Was This Recalled?
IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Beckman Coulter, Inc.
Beckman Coulter, Inc. has 79 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report