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Fujirebio Diagnostics, Inc. Recalls

4 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Fujirebio Diagnostics, Inc..

4Total Recalls
0Critical
467Units Affected
Dec 11, 2025Most Recent
All Recalls

Every Fujirebio Diagnostics, Inc. Recall

Sorted by most recent. Click any recall for full details.

4 recalls
High RiskFDA
Fujirebio Diagnostics, Inc.
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: Lum...
Medical Implants·148 affected·Dec 11, 2025
High RiskFDA
Fujirebio Diagnostics, Inc.
Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description...
Medical Devices·117 affected·Dec 11, 2025
High RiskFDA
Fujirebio Diagnostics, Inc.
Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Applicable Product De...
Diagnostic Devices·23 affected·Dec 11, 2025
High RiskFDA
Fujirebio Diagnostics, Inc.
Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Product Description: Lu...
Medical Implants·179 affected·Dec 11, 2025