Reported Feb 11, 2026 · Ongoing
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product…
Fujirebio Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fujirebio Diagnostics, Inc. · 201 Great Valley Pkwy · Malvern, PA · 19355-1308
Is this the product you have?
- Product NameLumipulse pTau 217
- Plasma Controls Model/Catalog Number81558
- Software VersionNot
- Applicable Product DescriptionLumipulse
- pTau 217 Plasma ControlsThis quality control product can be used as an objective judgement of the laboratory s procedures and personnel techniques when analyzing pTau 217 in K2EDTA plasma on the LUMIPULSE G System. It is a valuable tool to assess good laboratory practices. Two levels of control are available to compare observations with expected ranges therefore assuring consistent performance of the testing system within the clinical range
- Lumipulse pTau 217 Plasma ControlsLiquid (Frozen), 2 ¿2 Concentrations L1 Level 1 (2¿ 1.5 mL) L2 Level 2 (2¿ 1.5 mL) Contains Tris buffer with protein (bovine) and chemical stabilizers
- Preservative
0.1% ProClin 3000.05%
- ProClin 950 ComponentYes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
- Lot codes and dates
- Model/Catalog Number81558
- UDI-DI05414470815586
- Lot Numbers
D6C6092UD6C6092U1D6C6123U
- Amount recalled
- 148 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was 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).
This product could cause temporary or reversible health problems — stop using it.
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