Fujirebio recalls Lumipulse G Amyloid 1-42 Plasma Immunoreaction Cartridges (Model 235447) due to potential inaccurate Alzheimer's disease test results. Affected users should contact the manufacturer for guidance.
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 Lumipulse G Amyloid 1-42 Plasma Immunoreaction Cartridges (Model 235447) because they may produce inaccurate test results for Alzheimer's disease. This could lead to incorrect diagnoses or unnecessary additional testing.
The cartridges may show a higher frequency of indeterminate or positive results when compared to FDA-cleared CSF ratio or PET imaging tests. This can cause patients to be incorrectly classified as having Alzheimer's disease or require more clinical testing than necessary.
Users of the Lumipulse G Amyloid 1-42 Plasma Immunoreaction Cartridges (Model 235447) for Alzheimer's disease testing. Patients undergoing diagnostic testing for Alzheimer's disease are most at risk of receiving incorrect results.
The product is labeled as Lumipulse G Amyloid 1-42-N Plasma Immunoreaction Cartridges with model number 235447. It was sold with the LUMIPULSE G System for plasma testing.
Reach out to Fujirebio Diagnostics, Inc. for guidance on next steps.
The cartridges may produce inaccurate test results for Alzheimer's disease, leading to incorrect classifications or unnecessary additional testing.
Contact Fujirebio Diagnostics, Inc. for guidance on next steps.
No serious injury risk is described in the recall notice; the hazard is related to inaccurate test results.
We’ve drafted a message you can send Fujirebio to request your refund or repair — edit it as you like.
Subject: Recall Z-1305-2026 — Fujirebio Fujirebio Hello, I own a Fujirebio that is covered by recall Z-1305-2026 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.
