Fujirebio recalls Lumipulse Amyloid Plasma Controls (model 81559) due to potential inaccurate Alzheimer's test results. Customers may get false positive or indeterminate results affecting diagnosis.
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).
Fujirebio is recalling its Lumipulse Amyloid Plasma Controls (model 81559) because they can cause inaccurate Alzheimer's disease test results. This means patients might be incorrectly diagnosed as having amyloid pathology or require unnecessary additional testing.
The product can produce false positive or indeterminate results when testing for amyloid pathology in Alzheimer's disease. This happens because the test may show a higher frequency of classification errors compared to FDA-cleared methods like CSF ratio or PET imaging.
Laboratories using the Lumipulse Amyloid Plasma Controls (model 81559) for Alzheimer's testing may be affected. Patients relying on these tests for diagnosis could face incorrect results.
Check for the model number 81559 on the Lumipulse Amyloid Plasma Controls product. This product was sold with the UDI-DI 05414470815593 and lot number T8B6116U.
Look for the model number 81559 on the Lumipulse Amyloid Plasma Controls product.
The product can cause inaccurate Alzheimer's disease test results by producing false positive or indeterminate results when compared to FDA-cleared methods like CSF ratio or PET imaging.
Patients may be incorrectly diagnosed as having Alzheimer's disease or require unnecessary additional testing due to inaccurate test results.
Check for the model number 81559 on the Lumipulse Amyloid Plasma Controls product. This product was sold with the UDI-DI 05414470815593 and lot number T8B6116U.
We’ve drafted a message you can send Fujirebio to request your refund or repair — edit it as you like.
Subject: Recall Z-1307-2026 — Fujirebio Fujirebio Hello, I own a Fujirebio that is covered by recall Z-1307-2026 from Fujirebio. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
