Quick Facts at a Glance
- Recall Date
- December 11, 2025
- Hazard Level
- HIGH
- Brand
- Fujirebio Diagnostics
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- Plasma Calibrator
- Model numbers
- Model/Catalog Number: 81557, UDI-DI: 05414470815579, Lot Numbers: D5C6094U, D5C6125U
- Sold at
- Unknown
- 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 Calibrators are used in medical testing to assess pTau 217 plasma concentrations, which can indicate Alzheimer's disease. These calibrators are essential for ensuring accurate test results in diagnosing conditions related to neurodegeneration.
Why This Is Dangerous
The product may produce falsely elevated positive or indeterminate results, leading to incorrect classifications of amyloid pathology in patients. This could result in unnecessary additional testing or misdiagnosis.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects both healthcare providers and patients, potentially leading to misdiagnosis and unnecessary clinical interventions.
Practical Guidance
How to identify if yours is affected
- Check the model number: 81557 on the product packaging.
- Verify lot numbers: D5C6094U or D5C6125U.
- Contact Fujirebio Diagnostics if you are unsure about your product.
Where to find product info
Serial numbers and lot numbers can typically be found on the product label or packaging.
What timeline to expect
Expect a timeline of 4-8 weeks for refund processing after submitting the recall instructions.
If the manufacturer is unresponsive
- Contact Fujirebio Diagnostics again for follow-up.
- Document all correspondence related to the recall.
How to prevent similar issues
- Always verify product recalls through official channels before using medical devices.
- Look for FDA clearance on medical products to ensure safety standards are met.
Documentation advice
Keep records of all communications regarding the recall, including any letters received from the manufacturer.
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Product Details
The recalled product is the Lumipulse G pTau 217 Plasma Calibrator, Model/Catalog Number 81557. The product includes five concentrations: CAL 1 (0 pg/mL), CAL 2 (0.250 pg/mL), CAL 3 (1.000 pg/mL), CAL 4 (5.000 pg/mL), and CAL 5 (10.000 pg/mL). It was distributed across several states in the U.S.
Key Facts
- Product distributed nationwide
- Potential for misdiagnosis
- High hazard level
- Class II recall
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