The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipoprotein particles. This cholesterol is consumed by cholesterol esterase, cholesterol oxidase, peroxidase and 4- aminoantipyrine to generate a colorless end product. In phase two a second detergent in reagent 2 releases cholesterol from the LDL lipoproteins. This cholesterol reacts with cholesterol esterase, cholesterol oxidase and a chromogen system to yield a blue color complex which can be measured bichromatically at 540/660nm. The resulting increase in absorbance is directly proportional to the LDL-C concentration in the sample.
Recall
- Recall Number
- Z-1135-2026
- Event Number
- 98094
- Firm
- Beckman Coulter Ireland, Inc. Lismeehan O'Callaghan'S Mills Ireland
- FEI Number
- 1000206808
- Product Code
- LBS
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- December 8, 2025
- Posted
- January 21, 2026
Description
The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipoprotein particles. This cholesterol is consumed by cholesterol esterase, cholesterol oxidase, peroxidase and 4- aminoantipyrine to generate a colorless end product. In phase two a second detergent in reagent 2 releases cholesterol from the LDL lipoproteins. This cholesterol reacts with cholesterol esterase, cholesterol oxidase and a chromogen system to yield a blue color complex which can be measured bichromatically at 540/660nm. The resulting increase in absorbance is directly proportional to the LDL-C concentration in the sample.
Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU). LDL Cholesterol reagent showed clinically significant interference due to triglyceride concentration up to 1500 mg/dL may cause a maximum positive bias of up to 28.8% in low LDL Cholesterol samples (concentration 80 mg/dL) and up to 11.02% in high LDL Cholesterol samples (concentration 160mg/dL).
On 12/8/2025, recall notices were mailed and emailed to customers who were informed of the following: A clinically significant interference due to triglyceride concentration up to 1500mg/dL may cause a maximum positive bias of up to 28.8% in low LDL Cholesterol samples (concentration 80mg/dL) and up to 11.02% in high LDL Cholesterol samples (concentration 160mg/dL). Discontinuance or disposal of this product is not necessary. The LDL Cholesterol reagent can be used with the revised Instructions for Use (IFU) that contain the updated triglyceride interference specifications. Share the content of this letter with your laboratory and/or Medical Director. Retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter. Complete and return the response form via email to [email protected] If you have any questions regarding this notice, please contact our Customer Support Center: http://www.beckmancoulter.com, or 1-800-854-3633 in the United States.
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