Z-1305-2026Class II

Product Name: Lumipulse G -Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number: 235447...

Name: Z-1305-2026 Product Name: Lumipulse G -Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number: 235447...
Creator: Fujirebio Diagnostics, Inc.
Published: 2025-12-11
License: https://open.fda.gov/license/

Fujirebio Diagnostics, Inc. / initiated 2025-12-11 / Open, Classified

FDA source

Fujirebio Diagnostics, Inc. began a recall of Product Name: Lumipulse G -Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number: 235447 Software Version: Not Applicable Product Description... on 2025-12-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1305-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-11
Posted: 2026-02-05
Recalling firm: Fujirebio Diagnostics, Inc.
Product: 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
Product code: SET Immunoassay Blood Test For Amyloid Pathology Assessment
Reason for recall: 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: Under Investigation by firm
Action: 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.
Quantity in commerce: 1423 units
Distribution: US Nationwide distribution in the states of Arizona, California, Florida, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Minnesota, New Jersey, Pennsylvania, Texas, Washington.
Product codes and lots: Model/Catalog Number: 235447; UDI-DI: 04987270235447; Lot Numbers: C5C6022U, C5C6045U;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1305-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1301-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-05
Z-1302-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-05
Z-1303-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-05
Z-1304-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-05
Z-1305-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-05
Z-1306-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-05
Z-1307-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-11	2026-02-05

Product code SET

K242706Class IILumipulse G pTau217/ß-Amyloid 1-42 Plasma RatioFujirebio Diagnostics,Inc. / cleared 2025-05-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)