Device product
Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
Z-2322-2025
Product summary
- Event
- Event 97255
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 453 units
- Official record key
device-enforcement:Z-2322-2025
Official wording
Reason: 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.
Code information: UDI-DI: 15099590227173; Lot Number: 439163
Distribution pattern: Worldwide - US Nationwide and the countries of Brazil, Canada, Georgia, Italy, Malaysia, Mexico, Philippines, Spain.
Derived failure modes
-
Unknown
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.