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
- In Vitro Diagnostic Test
- Model numbers
- Model/Catalog Number: CL0073, UDI-DI: 00869164000086, Distribution for Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio ("Ratio") is related to the "Ratio" Instructions for Use (IFU). Therefore, each consignee has 1 "Ratio" in which they purchase the component kits for.
- 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 pTau217/B-Amyloid 1-42 Plasma Ratio is an in vitro diagnostic test that combines results from two assays to help assess amyloid pathology associated with Alzheimer's disease. Healthcare providers typically use this product for diagnosing patients based on plasma samples.
Why This Is Dangerous
The risk arises from the potential for the test to yield falsely elevated positive or indeterminate results, which can misclassify a patient's condition and lead to inappropriate clinical decisions.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may lead to significant inconvenience for healthcare providers and patients, as it requires reevaluation of test results and may result in unnecessary additional testing.
Practical Guidance
How to identify if yours is affected
- Check the model number on your product packaging or device.
- Verify if the model number is CL0073, as this indicates it is part of the recall.
- Review any notification letters received regarding the recall.
Where to find product info
The model number can typically be found on the product's packaging or the instruction manual included with the test kit.
What timeline to expect
Expect a response regarding refunds or replacements within 4-6 weeks after contacting Fujirebio Diagnostics.
If the manufacturer is unresponsive
- Follow up with Fujirebio Diagnostics if you do not receive a timely response.
- Keep a record of all communications regarding the recall.
How to prevent similar issues
- Inquire about FDA approval status when purchasing diagnostic tests in the future.
- Check for recent recalls on medical devices before use.
Documentation advice
Document all correspondence regarding the recall, including emails and phone calls, and keep any receipts or proof of purchase.
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Product Details
The Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio test, Model CL0073, combines results from two assays into a numerical ratio. The product was distributed nationwide in 13 states, including California and Florida.
Key Facts
- Inaccurate test results risk misclassification
- Stop using device and follow recall instructions
- Distributed in 13 U.S. states
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