FDA recall, , Moderate risk
Beckman Coulter LDL-Cholesterol Assay
Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU).
Summary by Recall Canary from the FDA notice
What happened
Beckman Coulter Ireland, Inc. recalled the LDL-Cholesterol assay, specifically LDL Cholesterol OSR6x96, after identifying that it is not meeting the performance claim listed in the Instructions for Use (IFU).
The reagent showed clinically significant interference due to triglyceride concentration up to 1500 mg/dL, which 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). The recall began December 8, 2025, and was added to the FDA's Enforcement Report on January 21, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your can affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Product details
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.
- UDI-DI
- 15099590010928
- 15099590020361
- Lot code
- All Lots and Expiration Dates. IFU Version BAOSR6X96-10 and prior.
Recall details
- Company began the recall
- Sold in
US: Maryland, New Jersey, Ohio, Florida, California, Texas, North Carolina, Washington, Massachusetts, Nevada, Georgia, Colorado, Pennsylvania, New Mexico, Utah, Virginia, Kansas, Montana, Oklahoma, New York, Arizona, Louisiana, Oregon, Alabama, Missouri, Indiana, Illinois, Kentucky, Mississippi, New Hampshire, Alaska, South Dakota, Minnesota, Tennessee, PR, Michigan, Iowa, Wisconsin, West Virginia, Maine, South Carolina, Hawaii, Rhode Island, North Dakota, Nebraska, Idaho, Arkansas, Wyoming, District of Columbia, GU, Delaware, Connecticut. OUS: Brazil, South Africa, Argentina, Mexico, Canada, Costa Rica, Peru, El Salvador, Ecuador, Panama, Singapore, Ireland, United Kingdom of Great Britain and Northern Ireland, Germany, China, Korea, Republic of
- Company
- Beckman Coulter Ireland, Inc.O'Callaghan'S Mills, Ireland
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98094
- Recall number
- Z-1135-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
