FDADecember 11, 2025device

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 personnel techniques when an...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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 to do

FDA enforcement status: Ongoing

Brands named

fujirebio diagnosticsfujirebio

UPCs

05414470815586

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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