FDA recall, , Moderate risk
Fujirebio Lumipulse G Plasma Assays, Calibrators and Controls
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.
Summary by Recall Canary from the FDA notice
What happened
Fujirebio Diagnostics, Inc., of Malvern, Pennsylvania, recalled several Lumipulse G products, including calibrators, immunoreaction cartridges, controls, and a plasma ratio test, because customers may experience inaccurate test results.
The issue involves a higher frequency of classification in the indeterminate and positive zone and/or low specificity compared to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive or indeterminate ratio results, which could incorrectly classify a patient as having amyloid pathology associated with Alzheimer's disease or require more clinical testing.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
7 products
Match the UDI-DI, lot code and model/catalog number listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Lumipulse G pTau 217 Plasma Calibrators
- UDI-DI
- 05414470815579
- Model/Catalog number
- 81557
- Lot code
- D5C6094U
- D5C6125U
Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio
- UDI-DI
- 00869164000086
- Model/Catalog number
- CL0073
Lumipulse G pTau 217 Plasma Immunoreaction Cartridges
- UDI-DI
- 05414470815500
- Model/Catalog number
- 81550
- Lot code
- D4C6028U
- D4C6029U
- D4C6051U
- D4C6052U
Lumipulse ¿-Amyloid Plasma Controls
- UDI-DI
- 05414470815593
- Model/Catalog number
- 81559
- Lot code
- T8B6116U
Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges
- UDI-DI
- 04987270235447
- Model/Catalog number
- 235447
- Lot code
- C5C6022U
- C5C6045U
Lumipulse pTau 217 Plasma Controls
- UDI-DI
- 05414470815586
- Model/Catalog number
- 81558
- Lot code
- D6C6092U
- D6C6092U1
- D6C6123U
Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators
- UDI-DI
- 04987270235454
- Model/Catalog number
- 235454
- Lot code
- D8C6022U
- D8C6044U
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washington.
- Company
- Fujirebio Diagnostics, Inc.Malvern, Pennsylvania
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98232
- Recall numbers
- Z-1301-2026 to Z-1307-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
