Back to RecallTracker
Health Canada Medical devices

Beckman Coulter AU Immunochemistry System- HDL/LDL Cholesterol Assay

Issued December 10, 2025
Issue
LDL cholesterol OSR6x96 does not meet the triglyceride interference claim per the BAOSR6x96 v10 IFU which states "no significant interference up to 1,500 mg/dl triglyceride" where the criteria for no significant interference is recovery within 10% of the initial value as outlined in the IFU.
Hazard description
Performance
Product
Product name
Beckman Coulter AU Immunochemistry System- HDL/LDL Cholesterol Assay
Reference
ID
RA-81343