Fujirebio Diagnostics has recalled 117 units of Lumipulse G pTau 217 Plasma Calibrators due to inaccurate test results. The recall was announced on December 11, 2025, after customers reported false classifications of Alzheimer’s disease. Affected products were distributed nationwide, including in states like California and Florida.
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).
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Fujirebio Diagnostics, Inc. or your healthcare provider for instructions. Notification method: Letter
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
The Lumipulse G pTau 217 Plasma Calibrators are used in medical testing to assess pTau 217 plasma concentrations, which can indicate Alzheimer's disease. These calibrators are essential for ensuring accurate test results in diagnosing conditions related to neurodegeneration.
The product may produce falsely elevated positive or indeterminate results, leading to incorrect classifications of amyloid pathology in patients. This could result in unnecessary additional testing or misdiagnosis.
This recall is not part of a broader industry pattern.
The recall affects both healthcare providers and patients, potentially leading to misdiagnosis and unnecessary clinical interventions.
Serial numbers and lot numbers can typically be found on the product label or packaging.
Expect a timeline of 4-8 weeks for refund processing after submitting the recall instructions.
Keep records of all communications regarding the recall, including any letters received from the manufacturer.
The recalled product is the Lumipulse G pTau 217 Plasma Calibrator, Model/Catalog Number 81557. The product includes five concentrations: CAL 1 (0 pg/mL), CAL 2 (0.250 pg/mL), CAL 3 (1.000 pg/mL), CAL 4 (5.000 pg/mL), and CAL 5 (10.000 pg/mL). It was distributed across several states in the U.S.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
Mazda North American Operations is recalling 2024 CX-90 and 2025 CX-70 SUVs sold through Mazda dealers. The PCM and ECM software can illuminate malfunction indicator lights and cause a loss of drive power, increasing crash risk. Owner notification letters were mailed December 19, 2024, and Mazda will reprogram the PCM and ECM at no charge.
Mazda North American Operations recalls 2025 Mazda CX-70 plug-in hybrids as software issues in the inverter may cause the malfunction indicator lights to illuminate and a loss of drive power in EV mode. Dealers will update inverter software at no cost. Letters were mailed December 19, 2024.
Mazda North American Operations recalls certain 2024-2025 CX-90 and 2025 CX-70 vehicles with a Dash ESU due to startup function failures. Software reprogramming will remedy the issue at no charge. Owner notices were mailed December 18, 2024. Contact Mazda at 1-800-222-5500 Option 6. NHTSA ID 24V814000.
Subaru recalls 2025 Forester vehicles due to potentially loose child seat anchor bolts. Dealers will inspect and tighten bolts at no charge. Owner letters are expected August 15, 2025. Contact Subaru at 1-844-373-6614. Recall number WRC-25.
Nissan recalls 2025 Pathfinder, Murano and INFINITI QX60 for front brake caliper weakness that could fail. Dealers will inspect and replace calipers as needed, free of charge. Letters sent May 9, 2025. Contact Nissan or INFINITI for remedies.
Mazda North American Operations is recalling 2025 CX-50 Hybrid and CX-50 SUVs sold through Mazda dealers. Incorrectly configured restraint-control software may cause the air bag to deploy improperly. Owner notification letters are expected to be mailed August 17, 2025.
Nissan North America is recalling certain 2025 Nissan Kicks vehicles sold through Nissan dealers nationwide. The certification label may print incorrect GVWR and GAWR values, risking overload. Some SR trims with a 19-inch wheel package may display an incorrect wheel size on the label, and owners should contact their Nissan dealer to arrange replacement labels.
BMW recalls 2025-2026 X1 and X2 models plus MINI Cooper and Countryman variants for front seat belt retractors with damaged torsion bars. The defect may fail to restrain occupants in a crash. Dealers will replace both front retractors at no cost. Owner letters begin November 7, 2025. VIN lookup will be available on NHTSA.gov the same day.