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The LDL-Cholesterol assay is comprised of two distinct… recallZ-1135-2026 · Beckman Coulter Ireland, Inc. · initiated Dec 8, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Beckman Coulter Ireland, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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).

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-1135-2026
Status
Open, Classified
Initiated by the company
Dec 8, 2025
Posted by the FDA
Jan 21, 2026
Recalling firm
Beckman Coulter Ireland, Inc.
Quantity
34,451
Product code
LBS
FDA submissions
K040471
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

Product description

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.

Code information (models, lots, serial numbers)

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

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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