Medical Device Recall: Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
Beckman Coulter, Inc. · July 10, 2025
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.
States Affected
NATIONWIDE
Quantity Affected
453 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2322-2025
Status: ongoing
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