CanadaBeckman Coulter AU Immunochemistry System HDL/LDL Cholesterol Assay (models OSR6196 and OSR6296; affected lot/serial numbers: more than 10 — contact the manufacturer for specifics) is affected. The LDL cholesterol OSR6x96 assay does not meet the triglyceride interference claim in the BAOSR6x96 v10 IFU, which states no significant interference up to 1,500 mg/dL triglyceride based on recovery within 10% of the initial value. Contact the manufacturer, Beckman Coulter, Inc., for additional information.
What's being recalled
Companies: Beckman Coulter, Inc., 250 S. Kraemer Blvd., Brea, California, United States, 92821.
How to identify it
Affected products: Beckman Coulter AU Immunochemistry System- HDL/LDL Cholesterol Assay; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue: OSR6196
Affected products: Beckman Coulter AU Immunochemistry System- HDL/LDL Cholesterol Assay; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue: OSR6296
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States