Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not
Pending LLM rewrite. Source: FDA_DEVICE Z-1304-2026.
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 pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: Lumipulse pTau 217 Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and personn
- 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 (5)
- Model/Catalog Number: 81558
- UDI-DI: 05414470815586
- Lot Numbers: D6C6092U
- D6C6092U1
- D6C6123U
Distribution
Distributed nationwide across the United States.
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