Fujirebio recalls Lumipulse G Amyloid 1-42 Plasma Calibrators (model 235454) due to potential inaccurate Alzheimer's test results. Affected users may get false positive or indeterminate results.
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-N Plasma Calibrators (model 235454) because they may cause inaccurate Alzheimer's disease test results. This could lead to false positive or indeterminate results that require unnecessary clinical testing.
The calibrators may produce false positive or indeterminate results when compared to FDA-cleared CSF ratio or PET imaging. This can lead to incorrect classification of patients as having Alzheimer's disease, requiring additional clinical testing.
Healthcare providers using the Lumipulse G Amyloid 1-42-N Plasma Calibrators for Alzheimer's disease testing are most at risk. Patients relying on these calibrators for diagnostic accuracy may be affected.
Check for the model number 235454 on the calibrator packaging. The product was sold with software version 'Not Applicable'.
Verify the model number on the calibrator packaging to confirm if it is 235454.
The Lumipulse G Amyloid 1-42-N Plasma Calibrators may cause inaccurate Alzheimer's disease test results, leading to false positive or indeterminate results.
Check the model number on the packaging. If it is 235454, you may need to contact Fujirebio for further instructions.
The recall is for potential inaccurate test results, not a physical hazard. There is no risk of serious injury.
We’ve drafted a message you can send Fujirebio to request your refund or repair — edit it as you like.
Subject: Recall Z-1306-2026 — Fujirebio Fujirebio Hello, I own a Fujirebio that is covered by recall Z-1306-2026 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.
