Thyroglobulin Antibody Assay Instructions Incorrectly State Biotin Interference Resolution
Beckman Coulter is recalling over 465,000 thyroglobulin antibody test kits because their instructions incorrectly state that biotin interference was addressed. The false information could lead to false-low test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a labeling error that creates risk of patient harm. Instructions incorrectly state that biotin interference was remediated, which could result in false-low test results and affect clinical decision-making for thyroid cancer patients. No illnesses or injuries have been reported, placing this at the High severity level per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Beckman Coulter, Inc. is recalling approximately 465,481 units of the Access Thyroglobulin Antibody II (TgAb) assay kit nationwide, including Puerto Rico, and in Mexico. The recall affects all instruction document part numbers B14994, B63978, and A38168 for kits shipped from July 2021 to the present.
The instructions for use incorrectly state that biotin interference in the assay has been remediated. This false statement could lead clinicians and laboratories to obtain inaccurate test results, potentially resulting in false-low thyroglobulin antibody measurements.
Thyroglobulin antibody levels are used to monitor patients with a history of thyroid cancer. False-low results could affect clinical decision-making and patient care. Beckman Coulter is working with laboratories and healthcare providers to correct the instructions and notify affected facilities.
The recalled product
- Product
- 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…
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 465,481
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- All IFU Part Numbers B14994
- B63978
- and A38168 affect all product/lots shipped from Jul-2021 to current
- UDI-DI 15099590202910.
Distribution
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