Fujirebio recalls Lumipulse pTau 217 Plasma Controls (model 81558) 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 Lumipulse pTau 217 Plasma Controls (model 81558) because they may cause inaccurate Alzheimer's disease test results. This could lead to incorrect diagnoses or unnecessary additional testing.
The product may produce false positive or indeterminate results when testing for Alzheimer's disease. This happens because the controls might show falsely elevated ratios, leading to incorrect classifications of patients as having amyloid pathology.
Laboratories using Lumipulse pTau 217 Plasma Controls (model 81558) for Alzheimer's testing may be affected. Patients relying on these controls for accurate diagnosis could face incorrect results.
Check for the model number 81558 on the product label. The product was sold with lot numbers D6C6092U, D6C6092U1, and D6C6123U. It comes in a frozen liquid form with two concentration levels.
Look for the model number 81558 on the product label to confirm if it's affected.
The product may cause inaccurate Alzheimer's disease test results by showing falsely elevated ratios, leading to incorrect classifications of patients as having amyloid pathology.
If you're using this product, your test results might be inaccurate, potentially leading to incorrect diagnoses or unnecessary additional testing.
Check the product label for model number 81558. The affected lot numbers are D6C6092U, D6C6092U1, and D6C6123U.
We’ve drafted a message you can send Fujirebio to request your refund or repair — edit it as you like.
Subject: Recall Z-1304-2026 — Fujirebio Fujirebio Hello, I own a Fujirebio that is covered by recall Z-1304-2026 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.
