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FDA-Device2026-01-28Class IIPROCESSING DEFECT

Beckman Coulter LDL Cholesterol OSR6x96 reagent recalled for inaccurate results in high-triglyceride samples

Beckman Coulter
FALSE CLAIMSNationwide distribution

Stop using Beckman Coulter LDL Cholesterol OSR6x96

Beckman Coulter's LDL Cholesterol OSR6x96 reagent may give inaccurate test results when patients have high triglyceride levels (above 1500 mg/dL). The test can overestimate LDL cholesterol by up to 29% in some samples, which could affect patient care decisions.

  • Stop using LDL Cholesterol OSR6x96 reagent (all lots, IFU Version BAOSR6X96-10 and earlier)
  • Contact Beckman Coulter for instructions on returning affected reagent kits
  • Review recent test results for patients with high triglyceride levels and consider retesting with an alternative method
Hazard

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).

Sold states
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
Affected count
34,451
Manufactured in
Lismeehan, O'Callaghan'S Mills, Ireland
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1135-2026

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