FDAHealthJuly 10, 2025
Beckman Coulter, Inc. — Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
⚠️ Access Thyroglobulin reagent lot 439163 may generate erroneously high patient results. Falsely increased Access Thyroglobulin results may lead a physician to pursue unnecessary diagnostic imaging studies and/or inappropriate therapy adjustments in patients being monitored for residual or recurrent thyroid cancer.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 10, 2025
Worldwide - US Nationwide and the countries of Brazil, Canada, Georgia, Italy, Malaysia, Mexico, Philippines, Spain.
What's affected?
- Product
- Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
- Lot code
- 439163
Additional details
UDI-DI: 15099590227173; Lot Number: 439163
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 453 units.
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