Fujirebio recalls Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio test kits (CL0073) that may produce inaccurate Alzheimer's disease results due to false positives. Affected users should contact Fujirebio 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 pTau217/B-Amyloid 1-42 Plasma Ratio test kits (model CL0073) because they may give inaccurate results for Alzheimer's disease. This could lead to incorrect diagnoses or unnecessary follow-up tests. The issue affects users who rely on this test for early Alzheimer's detection.
The test may show false positive results for Alzheimer's disease, meaning it could incorrectly indicate a patient has the condition when they don't. This happens because the test might produce higher frequencies of indeterminate or positive classifications, leading to inaccurate ratios compared to FDA-cleared methods.
People using the Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio test (CL0073) for Alzheimer's disease screening are most at risk. This includes patients and healthcare providers who interpret the test results.
Check for the model number CL0073 on the test kit. The product is sold by Fujirebio Diagnostics, Inc. and is used for Alzheimer's disease plasma ratio testing.
Reach out to Fujirebio Diagnostics, Inc. for guidance on next steps as the recall remedy is not specified.
The test may produce inaccurate results for Alzheimer's disease due to false positives, which could lead to incorrect diagnoses or unnecessary follow-up tests.
The affected model is CL0073.
The recall remedy is not specified, so you should contact Fujirebio for guidance.
We’ve drafted a message you can send Fujirebio to request your refund or repair — edit it as you like.
Subject: Recall Z-1301-2026 — Fujirebio Fujirebio Hello, I own a Fujirebio that is covered by recall Z-1301-2026 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.
