CLASS II · ModerateFDA

Beckman Coulter Ireland, Inc. recalls The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique deter

📅 Dec 8, 2025 · 📍 AK, AL, AR, AZ, CA, CO, CT, DC +43

Recalling company: Beckman Coulter Ireland, Inc.
Product: 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.
Reason: 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).
Classification: Class II – may cause temporary or medically reversible health consequences
Recall date: Dec 8, 2025
Reported: Jan 28, 2026
Distribution: US: MD, NJ, OH, FL, CA, TX, NC, WA, MA, NV, GA, CO, PA, NM, UT, VA, KS, MT, OK, NY, AZ, LA, OR, AL, MO, IN, IL, KY, MS, NH, AK, SD, MN, TN, PR, MI, IA, WI, WV, ME, SC, HI, RI, ND, NE, ID, AR, WY, DC, GU, DE, CT. 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
Status: Ongoing
Quantity: 34,451
Lot / codes: REF/UDI-DI: OSR6196/15099590010928, OSR6296/15099590020361. All Lots and Expiration Dates. IFU Version BAOSR6X96-10 and prior.
Company location: O'Callaghan'S Mills
Recall type: Voluntary: Firm initiated
Recall number: Z-1135-2026
Agency: U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1135-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

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