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
- Immunoassay Reagents
- Model numbers
- Model/Catalog Number: 81550, UDI-DI: 05414470815500, Lot Numbers: D4C6028U, D4C6029U, D4C6051U, D4C6052U
- 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 pTau 217 Plasma Immunoreaction Cartridges are used for measuring pTau 217 levels in plasma specimens, which aids in diagnosing Alzheimer's disease. Healthcare professionals commonly use these cartridges in clinical settings to assess patients' cognitive health.
Why This Is Dangerous
The cartridges pose a risk of providing false classifications of Alzheimer's disease due to inaccurate test results. This can lead to misdiagnosis and unnecessary follow-up testing for patients.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients may experience delays in accurate diagnosis and treatment, leading to increased healthcare costs and emotional stress.
Practical Guidance
How to identify if yours is affected
- Check the model number on the cartridge packaging for Model/Catalog Number: 81550.
- Verify the lot numbers against the affected list: D4C6028U, D4C6029U, D4C6051U, D4C6052U.
- Consult your healthcare provider if unsure about the product's status.
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 refund or replacement process to take approximately 4-6 weeks after returning the product.
If the manufacturer is unresponsive
- Contact customer service for follow-up.
- Document all interactions and requests for records.
- Consider filing a complaint with the FDA if unresponsive.
How to prevent similar issues
- Ensure that any medical device has FDA clearance before use.
- Always verify lot numbers and recall status for medical products.
- Stay informed about recalls and safety alerts in the healthcare industry.
Documentation advice
Keep a record of your purchase, any correspondence with the manufacturer, and photos of the product for your records.
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Product Details
The recall involves Lumipulse G pTau 217 Plasma Immunoreaction Cartridges, Model/Catalog Number: 81550. A total of 1,569 units were distributed across 13 states in the U.S.
Key Facts
- Recall date: December 11, 2025
- Active recall status
- Affected states: Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts,
- Minnesota, New Jersey, Pennsylvania, Texas, Washington
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Safety Guide
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