Reported Aug 20, 2025 · Ongoing
Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
Beckman Coulter, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter, Inc. · 1000 Lake Hazeltine Dr · Chaska, MN · 55318-1037
Is this the product you have?
- Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
- Lot codes and dates
- UDI-DI15099590227173
- Lot Number439163
- Amount recalled
- 453 units
Where it was sold
- Nationwide
- GA
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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