Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: 81550 So
Pending LLM rewrite. Source: FDA_DEVICE Z-1302-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
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 G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: 81550 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges (IRC): Lumipulse G pTau 217 Plasma is an assay system, including a set o
- 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 (6)
- Model/Catalog Number: 81550
- UDI-DI: 05414470815500
- Lot Numbers: D4C6028U
- D4C6029U
- D4C6051U
- D4C6052U
Distribution
Distributed nationwide across the United States.
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