Lumipulse B-Amyloid Plasma Controls 81559Recalls & reported problems
Fujirebio Europe · Lumipulse B-Amyloid Plasma Controls 2x2C, IVD-US · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
6 other recalls cover devices cleared under the same FDA submission (K242706); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Dec 11, 2025Class IIOpen, Classified
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).
Z-1307-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K242706. One submission often covers many models, so check the product and lot details in each record.
- Z-1305-2026 · Dec 11, 2025 · Open, ClassifiedProduct Name: Lumipulse G -Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number: 235447 Software Version: Not Applicable Product Description: Lumipulse G -Amyloid 1
- Z-1303-2026 · Dec 11, 2025 · Open, ClassifiedProduct Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Calibrators: The
- Z-1306-2026 · Dec 11, 2025 · Open, ClassifiedProduct Name: Lumipulse G -Amyloid 1-42-N Plasma Calibrators Model/Catalog Number: 235454 Software Version: Not Applicable Product Description: Lumipulse G -Amyloid 1-42-N Plasma C
- Z-1301-2026 · Dec 11, 2025 · Open, ClassifiedProduct Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Applicable Product Description: Lumipulse G pTau217/-Amyloid 1-42 P
- Z-1304-2026 · Dec 11, 2025 · Open, ClassifiedProduct Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: Lumipulse pTau 217 Plasma Controls: This quality
- Z-1302-2026 · Dec 11, 2025 · Open, ClassifiedProduct Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: 81550 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Im
Other Immunoassay Blood Test For Amyloid Pathology Assessment devices
- Lumipulse pTau 217 Plasma Controls 81558Fujirebio Europe · Immunoassay Blood Test For Amyloid Pathology Assessment1 recall0 reports
- Lumipulse G B-Amyloid 1-42-N Plasma Calibrator 235454Fujirebio Inc. · Immunoassay Blood Test For Amyloid Pathology Assessment1 recall0 reports
- Lumipulse G pTau 217 Plasma Calibrators 81557Fujirebio Europe · Immunoassay Blood Test For Amyloid Pathology Assessment1 recall0 reports
- Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio CL0073Fujirebio Diagnostics, Inc. · Immunoassay Blood Test For Amyloid Pathology Assessment1 recall0 reports
- Lumipulse G B-Amyloid 1-42-N Plasma 235447Fujirebio Inc. · Immunoassay Blood Test For Amyloid Pathology Assessment1 recall0 reports
- Lumipulse G pTau 217 Plasma Immunoreaction Cartridges 81550Fujirebio Europe · Immunoassay Blood Test For Amyloid Pathology Assessment1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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