Beckman Coulter Ireland, Inc.: 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 number

Z-1135-2026

Recalling firm

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.

Status

Open, Classified

Initiated

2025-12-08

Posted

2026-01-21

Terminated

not on file

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).

Root cause

Device Design

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 regaffairsfax@beckman.com 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.

Quantity

34,451

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

Lot, serial or model codes

REF/UDI-DI: OSR6196/15099590010928, OSR6296/15099590020361. All Lots and Expiration Dates. IFU Version BAOSR6X96-10 and prior.

510(k) numbers

K040471

PMA numbers

not on file

Product code

LBS

Firm FEI

1000206808

Firm city

Mills

Firm state

not on file

Firm country

Ireland

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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