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 Plasma Control
- Model numbers
- Model/Catalog Number: 81558, UDI-DI: 05414470815586, Lot Numbers: D6C6092U, D6C6092U1, D6C6123U
- 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 pTau 217 Plasma Controls are used in laboratories to ensure accurate testing of Alzheimer’s disease through plasma analysis. They help assess the performance of laboratory procedures and techniques.
Why This Is Dangerous
The controls may produce falsely elevated results for patients, leading to incorrect classifications regarding Alzheimer’s disease. This can result in unnecessary follow-up testing and misdiagnosis.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers relying on these products for accurate Alzheimer’s testing may face serious implications due to potential misdiagnosis. This could lead to emotional stress and unnecessary additional tests.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the product packaging or documentation.
- Verify the lot numbers against the recall list: D6C6092U, D6C6092U1, D6C6123U.
- Check for the recall notification letter you received from Fujirebio Diagnostics.
Where to find product info
Serial numbers and lot numbers can typically be found on the product label or accompanying documentation.
What timeline to expect
Expect a response regarding refunds or replacements within 4-6 weeks.
If the manufacturer is unresponsive
- Contact Fujirebio Diagnostics customer service directly.
- Document all communication attempts for your records.
How to prevent similar issues
- Always check for recalls on medical devices before use.
- Stay informed about new safety information from manufacturers.
Documentation advice
Keep a copy of your purchase receipt and any correspondence regarding the recall.
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Product Details
The recall affects the Lumipulse pTau 217 Plasma Controls, Model/Catalog Number: 81558. The product contains Tris buffer, bovine protein, and chemical stabilizers, with a preservative of ProClin. It was distributed nationwide across multiple states including California and Texas.
Key Facts
- Recall date: December 11, 2025
- High risk of inaccurate test results
- Stop use immediately
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Safety Guide
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