Fujirebio recalls Lumipulse G pTau 217 Plasma Calibrators (model 81557) due to potential inaccurate Alzheimer's test results from false positive/indeterminate classifications. Affected units may need clinical retesting.
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 pTau 217 Plasma Calibrators (model 81557) because they may produce inaccurate Alzheimer's disease test results. This could lead to incorrect patient classifications as having amyloid pathology or requiring additional clinical testing.
The calibrator may show falsely elevated positive or indeterminate ratios, causing the system to incorrectly classify patients as having Alzheimer's disease or requiring more testing. This happens due to measurement inaccuracies in the plasma calibrator.
Patients using this calibrator for Alzheimer's disease testing may be affected. Healthcare providers who order these calibrators for clinical use are most at risk of incorrect test results.
Check for the model number 81557 on the calibrator. The product was sold with lot numbers D5C6094U and D5C6125U. This calibrator is used for measuring pTau 217 in plasma samples.
Identify the model number 81557 and lot numbers D5C6094U or D5C6125U on the calibrator.
The calibrator may produce inaccurate Alzheimer's disease test results by showing falsely elevated positive or indeterminate ratios, leading to incorrect patient classifications.
Patients using this calibrator might receive incorrect results indicating Alzheimer's disease or requiring additional testing, which could affect their diagnosis.
Look for model number 81557 with lot numbers D5C6094U or D5C6125U on the calibrator.
We’ve drafted a message you can send Fujirebio to request your refund or repair — edit it as you like.
Subject: Recall Z-1303-2026 — Fujirebio Fujirebio Hello, I own a Fujirebio that is covered by recall Z-1303-2026 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.
