Beckman Coulter, Inc. is recalling approximately 465,481 kits of the Access Thyroglobulin Antibody II (TgAb) assay, a diagnostic tool used to measure antibody levels in human blood samples. The recall was initiated because the Instructions for Use (IFU) incorrectly stated that interference from biotin (a common supplement) had been fixed when it had not. This error affects all kits shipped from July 2021 to the present that include specific instruction manuals. Consumers should be aware that these tests were distributed nationwide across the United States, including Puerto Rico, and to Mexico.
The incorrect instructions may lead healthcare providers to believe the test is resistant to biotin interference, potentially resulting in false-low test results for patients taking biotin supplements. Such inaccurate results could lead to incorrect medical diagnoses or inappropriate patient management.
Correction of Instructions for Use (IFU)
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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