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FDA-Device2026-02-11Class IIPROCESSING DEFECT

Fujirebio Lumipulse G pTau 217 test cartridges recalled for inaccurate Alzheimer's disease results

Fujirebio
FALSE CLAIMSNationwide distribution

Stop using Fujirebio pTau 217 test cartridges

Fujirebio's Lumipulse G pTau 217 Plasma test cartridges (Model 81550) may produce inaccurate results, incorrectly classifying patients as having Alzheimer's-related amyloid pathology or flagging them for unnecessary further testing. The cartridges show higher rates of false-positive and false-indeterminate results compared to FDA-approved reference tests. Affected lot numbers are D4C6028U, D4C6029U, D4C6051U, and D4C6052U.

  • If your healthcare facility has these cartridges, stop using them immediately.
  • Contact Fujirebio Diagnostics for instructions on returning or disposing of affected lot numbers.
  • Notify your healthcare provider if you received an Alzheimer's disease test result using this cartridge—results may need to be reconfirmed with another approved test.
Hazard

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).

Sold states
US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washington.
Affected count
1569 units
Manufactured in
201 Great Valley Pkwy, N/A, Malvern, PA, United States
Products
Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: 81550 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges (IRC): Lumipulse G pTau 217 Plasma is an assay system, including a set of immunoassay reagents (Lumipulse G pTau 217 Plasma IRC), for the quantitative measurement of pTau 217 in K2EDTA plasma specimens based on chemiluminescent enzyme immunoassay (CLEIA) technology by a specific two-step immunoassay method on the LUMIPULSE G System. 3 ¿ 14 Tests: 3 racks, 14 IRCs per rack, 1 test per IRC. Each IRC contains (abbreviated contents): 1. Antibody-Coated Particle Solution: (Contains anti-phosphorylated Tau (217) monoclonal antibody (mouse)-coated particles). This solution contains gelatin and turns into gel at 15¿C or lower, 2. Enzyme-Labeled Antibody Solution: (Contains alkaline phosphatase (ALP)-labeled anti-Tau monoclonal antibodies (mouse) conjugate), 3. Assay Specific Solution: (Contains chemical stabilizers in 50 mM Tris buffer) Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1302-2026

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