Fujirebio recalls Lumipulse G pTau 217 plasma cartridges that may cause inaccurate Alzheimer's test results due to false positive or indeterminate readings. Affected units include specific model and lot numbers.
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 recalls Lumipulse G pTau 217 plasma cartridges that may produce false positive or indeterminate results for Alzheimer's disease testing. This could lead to incorrect diagnoses or unnecessary additional testing. The recall affects specific model numbers and lot numbers.
The cartridges may show higher frequencies of 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 or requiring more clinical testing than necessary.
Patients using the Lumipulse G pTau 217 plasma cartridges for Alzheimer's disease testing are affected. Those with specific model numbers and lot numbers are most at risk.
Check for model number 81550 and lot numbers D4C6028U, D4C6029U, D4C6051U, or D4C6052U on the cartridge packaging.
Look for model number 81550 and lot numbers D4C6028U, D4C6029U, D4C6051U, or D4C6052U on the cartridge packaging.
The Lumipulse G pTau 217 plasma cartridges may cause inaccurate Alzheimer's disease test results by showing higher frequencies of false positive or indeterminate readings compared to FDA-cleared CSF ratio or PET imaging.
Check the model number and lot numbers on the cartridge packaging. If it matches the affected model and lot numbers, 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 from using the product.
We’ve drafted a message you can send Fujirebio to request your refund or repair — edit it as you like.
Subject: Recall Z-1302-2026 — Fujirebio Fujirebio Hello, I own a Fujirebio that is covered by recall Z-1302-2026 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.
