Beckman Coulter recalled 34,451 units of its LDL Cholesterol OSR6x96 assay on December 8, 2025, due to significant performance interference. The recall affects multiple states in the U.S. and several countries internationally. Affected products may provide inaccurate LDL cholesterol readings, posing health risks to patients.
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).
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Beckman Coulter Ireland, Inc. or your healthcare provider for instructions. Notification method: Letter
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The recalled product is the LDL Cholesterol OSR6x96 assay, identified by model numbers REF/UDI-DI: OSR6196/15099590010928 and OSR6296/15099590020361. The assay was distributed in the U.S. and internationally, including countries like Brazil and Germany. All lots and expiration dates are affected.
The LDL Cholesterol reagent may show clinically significant interference due to triglyceride concentrations up to 1500 mg/dL. This can lead to a maximum positive bias of 28.8% in low LDL cholesterol samples and 11.02% in high LDL cholesterol samples, potentially misinforming diagnosis and treatment.
There have been no reported injuries or deaths related to this recall. The risk lies in the potential for incorrect LDL cholesterol readings, which could lead to inappropriate medical decisions.
Healthcare providers and patients should stop using the LDL Cholesterol OSR6x96 assay immediately. To follow the recall instructions, contact Beckman Coulter Ireland or consult your healthcare provider.
For further details, reach out to Beckman Coulter Ireland at [contact number not provided]. More information is available at the FDA recall website.
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