Lumipulse pTau 217 Plasma Controls recall
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: Lumipulse pTau 217…
Why was Lumipulse pTau 217 Plasma Controls recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model/Catalog Number: 81558; UDI-DI: 05414470815586; Lot Numbers: D6C6092U, D6C6092U1, D6C6123U;
- Product
- Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: Lumipulse pTau 217…
- Recalling firm
- Fujirebio Diagnostics, Inc.
- Quantity
- 148 units
- Distribution
- US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washington.
- Recall date
- February 11, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)