HIGHFDA DEVICE
Beckman Coulter Recalls LDL Cholesterol Assay Due to Performance Issues
Beckman Coulter recalled 34,451 units of its LDL Cholesterol OSR6x96 assay on December 8, 2025, due to significant performance interference. The recall affects multiple states in the U.S. and several countries internationally. Affected products may provide inaccurate LDL cholesterol readings, posing health risks to patients.
Beckman Coulter Ireland
Beckman Coulter