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Product Name: Lumipulse G -Amyloid 1-42-N Plasma… recallZ-1305-2026 · Fujirebio Diagnostics, Inc. · initiated Dec 11, 2025

Class II Open, Classified All recalls posted in February 2026

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Fujirebio Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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).

FDA root cause category: Under Investigation by firm

What the company is doing

On or about December 11, 2025 URGENT PRODUCT CORRECTION NOTIFICATION letters were sent to customers. Actions to be taken: - Immediately discontinue using the associated Lots listed above for the Lumipulse G pTau217/-Amyloid 1-42 Plasma Ratio. - Review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. - Notify your ordering physician or health care provider as appropriate. - The test results must be interpreted in conjunction with other diagnostic tools and clinical information. - Please retain this letter with your laboratory records and forward this leer to those who may have received this product.

Recall details

Recall number
Z-1305-2026
Recall class
Class II
Status
Open, Classified
Initiated by the company
Dec 11, 2025
Posted by the FDA
Feb 5, 2026
Recalling firm
Fujirebio Diagnostics, Inc.
Quantity
1423 units
Product code
SET
FDA submissions
K242706
Distribution
US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washington.

Product description

Product Name: Lumipulse G -Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number: 235447 Software Version: Not Applicable Product Description: Lumipulse G -Amyloid 1-42-N Plasma Immunoreaction Cartridges (IRC): Lumipulse G -Amyloid 1-42-N Plasma is an assay system, including a set of immunoassay reagents (Lumipulse G -Amyloid 1-42-N Plasma IRC), for the quantitative measurement of -Amyloid 1-42 in K2EDTA plasma specimens based on chemiluminescent enzyme immunoassay (CLEIA) technology13 by a specific two-step immunoassay method on the LUMIPULSE G System. Lumipulse G -Amyloid 1-42-N Plasma Immunoreaction Cartridges (IRC): 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--amyloid 1-42 monoclonal antibody (mouse)-coated particles). This solution contains gelatin and turns into gel at 15C or lower, 2. Enzyme-Labeled Antibody Solution: (Contains alkaline phosphatase (ALP)-labeled anti--amyloid 1-42 monoclonal antibodies (mouse) conjugate), 3. Assay Specific Solution: (Contains detergents in 50 mM MES buffer) Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio

Code information (models, lots, serial numbers)

Model/Catalog Number: 235447; UDI-DI: 04987270235447; Lot Numbers: C5C6022U, C5C6045U;

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

6 devices cleared under K242706 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 98232).

Sources and updates

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