Beckman Coulter, Inc.: Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide - US Nationwide and the countries of Brazil, Canada, Georgia, Italy, Malaysia, Mexico, Philippines, Spain. Quantity: 453 units Lot/code info: UDI-DI: 15099590227173; Lot Number: 439163

UPC codes

15099590227173

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.