Beckman Coulter, Inc. device recall (Cls II)

Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860 — 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. — Status: Ongoing