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: 235447, UDI-DI: 04987270235447, Lot Numbers: C5C6022U, C5C6045U
- 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 Immunoreaction Cartridges are used for quantitative measurement of ¿-Amyloid 1-42 in plasma specimens. They are primarily utilized in clinical settings to assist in the diagnosis of Alzheimer’s disease.
Why This Is Dangerous
The cartridges can yield inaccurate results, classifying patients incorrectly as having Alzheimer's pathology. This can lead to unnecessary further testing and misdiagnosis.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers may face delays in diagnosis and additional testing due to inaccurate results.
Practical Guidance
How to identify if yours is affected
- Check the model number for 235447.
- Verify the lot numbers: C5C6022U, C5C6045U.
- Confirm with your healthcare provider if you are using this product.
Where to find product info
The model number can usually be found on the product packaging or labeling.
What timeline to expect
Refund processing typically takes 4-6 weeks after the recalled product is returned.
If the manufacturer is unresponsive
- Contact Fujirebio Diagnostics again via their customer service.
- Document all communications and keep a record.
How to prevent similar issues
- Always check for product recalls before using medical devices.
- Look for FDA clearance when purchasing diagnostic tests.
- Consult healthcare professionals for alternative testing options.
Documentation advice
Keep receipts, communications with the manufacturer, and any records of your usage of the product.
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Product Details
The recalled product is the Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges, Model 235447. It includes 14 cartridges per rack and is distributed nationwide in states including California, Florida, and Texas. The product was sold as part of an assay system for measuring ¿-Amyloid 1-42 in K2EDTA plasma specimens.
Key Facts
- Potential for false positive results
- Distributed nationwide in the U.S.
- Class II recall status
- No reported injuries or deaths
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Safety Guide
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