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Open, Classified

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.

FDA Recall Z-1135-2026 · Posted 2026-01-21

Recalling FirmBeckman Coulter Ireland, Inc.
Recall StatusOpen, Classified
Product CodeLBS
Date Initiated2025-12-08
Product Quantity34,451

Reason for Recall

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).

Firm Action

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.

Root Cause

Device Design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040471OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296; OLYMPUS LDL CHOLESTEROL CALIBRATOR, ODC0024Olympus America, Inc. · 2004-03-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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