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
- Quality Control Testing Device
- Model numbers
- Model/Catalog Number: 81559, UDI-DI: 05414470815593, Lot Number: T8B6116U
- 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 ¿-Amyloid Plasma Controls are used as quality control in laboratories analyzing amyloid levels in plasma. They are essential for ensuring accurate test results in Alzheimer's disease diagnostics.
Why This Is Dangerous
The product may yield inaccurate results, causing patients to be misclassified regarding their Alzheimer's disease status. This can lead to unnecessary additional testing or incorrect treatment paths.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may lead to confusion and anxiety among patients awaiting test results, as well as potential delays in receiving appropriate care.
Practical Guidance
How to identify if yours is affected
- Check the model and catalog number on the product packaging.
- Verify if the lot number is T8B6116U.
- Consult any notification letters received from Fujirebio Diagnostics.
Where to find product info
Product model and lot numbers are typically found on the packaging or in the accompanying documentation.
What timeline to expect
Expect a refund or replacement processing time of approximately 4 to 8 weeks.
If the manufacturer is unresponsive
- Document all communications with the company.
- Reach out through alternative contact methods if no response is received.
How to prevent similar issues
- Look for FDA-approved diagnostic tests in the future.
- Verify that quality control products have clear labeling and regulatory approval.
- Stay informed about recalls in the medical device industry.
Documentation advice
Keep copies of your purchase receipt, recall notification letters, and any correspondence with the manufacturer.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recalled product is Lumipulse ¿-Amyloid Plasma Controls, Model/Catalog Number 81559. The product contains Tris buffer with protein and chemical stabilizers, and it was sold nationwide in the U.S. between unspecified dates.
Key Facts
- Recall date: December 11, 2025
- Inaccurate test results may misclassify Alzheimer's disease
- Contact Fujirebio for more instructions
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.