FDA Medical devices recall ·
Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay recall
- Recall number
- Z-2322-2025
- Date
- (initiated July 10, 2025)
- Company / brand
- Beckman Coulter, Inc.
1000 Lake Hazeltine Dr, Chaska, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 453 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 15099590227173; Lot Number: 439163
Distribution
Worldwide - US Nationwide and the countries of Brazil, Canada, Georgia, Italy, Malaysia, Mexico, Philippines, Spain.
States: Georgia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2322-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.