Quick Facts at a Glance
- Recall Date
- December 8, 2025
- Hazard Level
- HIGH
- Brand
- Beckman Coulter Ireland
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- Nationwide (50 states)
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Beckman Coulter Ireland
- Product type
- LDL Cholesterol Assay
- Model numbers
- REF/UDI-DI: OSR6196/15099590010928, OSR6296/15099590020361. All Lots and Expiration Dates. IFU Version BAOSR6X96-10 and prior.
- Sold at
- Multiple Retailers
- Where affected
- Nationwide
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 8, 2025
Reported by FDA DEVICE
January 28, 2026
RecallRadar source check
February 4, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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).
What You Should Do
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
About This Product
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.
Why This Is Dangerous
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.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
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.
Practical Guidance
How to identify if yours is affected
- Verify the model number against REF/UDI-DI: OSR6196/15099590010928 or OSR6296/15099590020361.
- Check for any communication from Beckman Coulter regarding this recall.
- Consult your healthcare provider for further confirmation.
Where to find product info
Model numbers can typically be found on the packaging or the assay box.
What timeline to expect
Expect a refund processing time of about 4 to 6 weeks after returning the product.
If the manufacturer is unresponsive
- Reach out to Beckman Coulter Ireland directly for assistance.
- Consider contacting the FDA or regulatory bodies for further guidance.
How to prevent similar issues
- Always verify the performance claims of medical devices before purchase.
- Look for products with established safety records and reliable certification.
- Stay informed about product recalls and safety notifications.
Documentation advice
Document any correspondence with Beckman Coulter and keep records of your purchase and communications regarding the recall.
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Product Details
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.
Key Facts
- Recalls 34,451 units of LDL Cholesterol OSR6x96 assay
- Potential bias in cholesterol readings up to 28.8%
- Distributed in multiple U.S. states and internationally
- Immediate cessation of use is advised
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Safety Guide
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