Quick Facts at a Glance
- Recall Date
- December 11, 2025
- Hazard Level
- HIGH
- Brand
- Fujirebio Diagnostics
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 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
- Fujirebio Diagnostics
- Product type
- Plasma Calibrators
- Model numbers
- Model/Catalog Number: 235454, UDI-DI: 04987270235454, Lot Numbers: D8C6022U, D8C6044U
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 11, 2025
Reported by FDA DEVICE
February 11, 2026
RecallRadar source check
February 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Fujirebio Diagnostics, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
The Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators are used in laboratory testing to measure amyloid plasma concentration, aiding in the diagnosis of Alzheimer's disease. These calibrators are essential for ensuring accurate test results in clinical settings.
Why This Is Dangerous
Inaccurate test results arise due to falsely elevated positive or indeterminate ratios. This can mislead healthcare providers into classifying patients incorrectly, potentially delaying necessary treatment or further testing.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may face significant implications due to the risk of misdiagnosis, leading to unnecessary anxiety and further clinical testing.
Practical Guidance
How to identify if yours is affected
- Check the model number: 235454.
- Verify lot numbers: D8C6022U or D8C6044U.
- Confirm that the product was purchased prior to December 11, 2025.
Where to find product info
The model and lot numbers are typically found on the product packaging or accompanying documentation.
What timeline to expect
Expect a timeline of 4-6 weeks for refund processing after returning the product.
If the manufacturer is unresponsive
- Follow up with Fujirebio Diagnostics in writing.
- Contact your healthcare provider for further assistance.
- File a complaint with the FDA if necessary.
How to prevent similar issues
- Look for FDA-cleared products in the future.
- Check for product reviews and safety certifications.
- Ensure calibration products are from reputable manufacturers.
Documentation advice
Keep all correspondence regarding the recall, including emails and letters. Document your return process with photos of the product.
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Product Details
The recalled product is Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators, Model Number 235454. These calibrators contain four concentrations and are distributed nationwide across various states including California and Texas. They were sold in liquid form, frozen, with volumes between 1 mL and 1.5 mL.
Key Facts
- Recall Date: December 11, 2025
- Distribution: Nationwide in the US
- Quantity Recalled: 128 units
- Class II recall designation
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Safety Guide
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