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 LDL Cholesterol OSR6x96 assay is used to measure cholesterol levels in patients, particularly LDL cholesterol, which is a key factor in assessing cardiovascular health. Healthcare providers rely on accurate measurements for diagnosing and managing patients with dyslipidemia.
This assay may inaccurately measure LDL cholesterol due to significant interference from high triglyceride levels, leading to potentially misleading results. This can result in either overestimating or underestimating a patient's cholesterol levels, impacting treatment decisions.
This recall is not part of a broader industry pattern.
Patients could face serious health risks due to inaccurate cholesterol readings, leading to inappropriate medical decisions. The recall may also cause inconvenience for healthcare providers needing to find reliable alternatives.
Model numbers can typically be found on the packaging or the assay box.
Expect a refund processing time of about 4 to 6 weeks after returning the product.
Document any correspondence with Beckman Coulter and keep records of your purchase and communications regarding the recall.
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.
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