FDA recall Z-2322-2025

Beckman Coulter, Inc. · Class II · device

Product

Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860

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.

Key facts

Status
Ongoing
Initiation date
2025-07-10
Report date
2025-08-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Chaska, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2322-2025