[pending] Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: No
Pending LLM rewrite. Source: FDA_DEVICE Z-1307-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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).
The recalled product
- Product
- Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Product Description: Lumipulse ¿-Amyloid Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and perso
- Manufacturer
- Fujirebio Diagnostics, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model/Catalog Number: 81559
- UDI-DI: 05414470815593
- Lot Number: T8B6116U
Distribution
Distributed nationwide across the United States.
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